# FDA Clinical Chemistry device clearances: 176 since Nov 2024

Updated October 30, 2026.

FDA made 176 device decisions in clinical chemistry (FDA review panel) from November 19, 2024 to October 30, 2026: 122 510(k) clearances and De Novo grants and 54 PMA approvals and supplements, for 69 applicants. The newest, K260738 on October 30, 2026, is Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System from Changsha Sinocare, Inc..

## The full list

FDA clinical chemistry device clearances and approvals: 176 rows for $8.80, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 8 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/clinical-chemistry

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 176
- 510(k) and De Novo: 122
- PMA: 54
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 176, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | K260738 | Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System | Changsha Sinocare, Inc. | China | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260738) |
| October 28, 2026 | K262242 | Profoject™ Safe Push Button Blood Collection Sets | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262242) |
| October 23, 2026 | K261293 | EASYMAX Voice Blood Glucose Monitoring System | EPS Bio Technology Corp. | Taiwan | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261293) |
| October 21, 2026 | K263422 | Mint ACE Pump | Beta Bionics, Inc. | California | Substantially Equivalent | 510(k) special | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263422) |
| October 21, 2026 | K260857 | Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | Illinois | Substantially Equivalent | 510(k) special | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260857) |
| October 20, 2026 | K262597 | Access BNP II | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262597) |
| October 16, 2026 | K252344 | BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) | Becton, Dickinson and Company | New Jersey | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252344) |
| October 15, 2026 | K262576 | twiist Loop Algorithm | Deka Research and Development Corp. | New Hampshire | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262576) |
| October 9, 2026 | K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual... | Vivachek Biotech (Hangzhou) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260687) |
| October 2, 2026 | K260689 | CVS Advanced PLUS Blood Glucose Monitoring System | I-Sens, Inc. | South Korea | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260689) |
| October 2, 2026 | K260468 | H100Plus Hemoglobin Testing System | Shenzhen Lifotronic Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PDJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260468) |
| September 29, 2026 | P160017/S140 | MiniMed 780G System | Medtronic Minimed, Inc. | California | Approved | PMA 180-day supplement | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S140) |
| September 25, 2026 | K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262215) |
| September 22, 2026 | K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | California | Substantially Equivalent | 510(k) traditional | JHI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262299) |
| September 21, 2026 | K262109 | Access NT-proBNP | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262109) |
| September 18, 2026 | K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | California | Substantially Equivalent | 510(k) traditional | SFU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262599) |
| September 16, 2026 | K261896 | iOS CamAPS FX | CamDiab | United Kingdom | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261896) |
| September 11, 2026 | K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | California | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262763) |
| September 11, 2026 | K260001 | Mint ACE Pump | Beta Bionics, Inc. | California | Substantially Equivalent | 510(k) traditional | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260001) |
| September 8, 2026 | K260062 | MODI System | DreaMed Diabetes, Ltd. | Israel | Substantially Equivalent | 510(k) traditional | QRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260062) |
| September 1, 2026 | P160030/S058 | Freestyle Libre Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | California | 30-day notice accepted | PMA 30-day notice | PZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160030S058) |
| September 1, 2026 | P150021/S061 | Freestyle Libre Pro Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | California | 30-day notice accepted | PMA 30-day notice | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150021S061) |
| September 1, 2026 | K260613 | AMI™ Plasma Cartridge, AMI™ | Sequitur Health Corp. | Arizona | Substantially Equivalent | 510(k) traditional | JID | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260613) |
| August 27, 2026 | K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System... | Ascensia Diabetes Care | New York | Substantially Equivalent | 510(k) traditional | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260545) |
| August 25, 2026 | DEN250049 | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care | California | Unknown | De Novo | SJD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250049) |
| August 11, 2026 | K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | California | Substantially Equivalent | 510(k) special | SBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262472) |
| August 5, 2026 | P160017/S139 | MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S139) |
| July 23, 2026 | K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | Florida | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262116) |
| July 21, 2026 | P250012/S011 | Simplera Sync | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S011) |
| July 21, 2026 | P160017/S138 | Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S138) |
| July 21, 2026 | P160007/S063 | Simplera System; Simplera Sync | Medtronic Minimed | California | 30-day notice accepted | PMA 30-day notice | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S063) |
| July 21, 2026 | P150001/S111 | Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC | Medtronic Minimed | California | 30-day notice accepted | PMA 30-day notice | OZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150001S111) |
| July 21, 2026 | P120010/S144 | Enlite Sensor | Medtronic, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120010S144) |
| July 9, 2026 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | California | Substantially Equivalent | 510(k) special | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261962) |
| June 29, 2026 | K261461 | Omnipod 6 algorithm | Insulet Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261461) |
| June 26, 2026 | K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | New Jersey | Substantially Equivalent | 510(k) traditional | CGL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261039) |
| June 18, 2026 | P220016 | HepQuant SHUNT® Liver Diagnostic Test | Hepquant, LLC | Colorado | Approved | PMA original approval | SIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220016) |
| June 17, 2026 | K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | New Hampshire | Substantially Equivalent | 510(k) special | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261672) |
| June 12, 2026 | P250012/S008 | Simplera Sync Sensor | Medtronic Minimed, Inc. | California | Approved | PMA real-time process supplement | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S008) |
| June 12, 2026 | P160017/S135 | MiniMed 780G System | Medtronic Minimed, Inc. | California | Approved | PMA real-time process supplement | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S135) |
| June 12, 2026 | P160007/S060 | Simplera system | Medtronic Minimed | California | Approved | PMA real-time process supplement | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S060) |
| June 12, 2026 | K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | California | Substantially Equivalent | 510(k) traditional | SBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260935) |
| June 12, 2026 | K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | Indiana | Substantially Equivalent | De Novo (dual track) | PZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252323) |
| June 11, 2026 | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | New Jersey | Substantially Equivalent | 510(k) traditional | MMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253051) |
| June 8, 2026 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | California | Substantially Equivalent | 510(k) traditional | QBJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261402) |
| June 2, 2026 | K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252899) |
| May 26, 2026 | P250012/S010 | Simplera and Simplera Sync | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S010) |
| May 26, 2026 | P160017/S137 | Simplera and Simplera Sync | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S137) |
| May 26, 2026 | P160007/S062 | Simplera and Simplera Sync | Medtronic Minimed | California | 30-day notice accepted | PMA 30-day notice | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S062) |
| May 21, 2026 | K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | California | Substantially Equivalent | 510(k) special | SAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261359) |
| May 1, 2026 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252488) |
| May 1, 2026 | K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | JGS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252475) |
| April 30, 2026 | K253976 | iLet ACE Pump | Beta Bionics, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253976) |
| April 24, 2026 | P110015/S012 | 13C-Spirulina Gastric Emptying Breath Test (GEBT) | Advanced Breath Diagnostics | Tennessee | Approved | PMA 180-day supplement | PGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110015S012) |
| April 24, 2026 | K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | California | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260429) |
| April 24, 2026 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | Germany | Substantially Equivalent | 510(k) traditional | JKR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252431) |
| April 15, 2026 | K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | New Jersey | Substantially Equivalent | 510(k) special | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260128) |
| April 15, 2026 | K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | CDZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252728) |
| April 10, 2026 | K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with... | Becton, Dickinson and Company | New Jersey | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252506) |
| April 10, 2026 | K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | New Jersey | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252378) |
| April 10, 2026 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252207) |
| April 2, 2026 | K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | QBV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250518) |
| April 2, 2026 | K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | QBV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250516) |
| March 24, 2026 | K252169 | Access BNP II | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252169) |
| March 19, 2026 | P250012/S009 | Simplera Sync Sensor | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S009) |
| March 19, 2026 | P160048/S031 | Eversense® Continuous Glucose Monitoring System | Senseonics, Incorporated | Maryland | Approved | PMA 180-day supplement | QCD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160048S031) |
| March 19, 2026 | P160017/S136 | Simplera Sync Sensor | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S136) |
| March 13, 2026 | K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | New Jersey | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252040) |
| March 12, 2026 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | California | Substantially Equivalent | 510(k) traditional | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253743) |
| February 27, 2026 | K251998 | Atellica CH Diazo Total Bilirubin (D\_TBil) | Siemens Healthcare Diagnostics, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | CIG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251998) |
| February 20, 2026 | K252619 | QSCHECK UISACR | Qstag, Inc. | South Korea | Substantially Equivalent | 510(k) traditional | JFY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252619) |
| February 18, 2026 | K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253539) |
| February 12, 2026 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) traditional | CEM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253491) |
| February 12, 2026 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) traditional | CFR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253490) |
| February 6, 2026 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | JLW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251543) |
| February 3, 2026 | K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM)... | Dexcom, Inc. | California | Substantially Equivalent | 510(k) traditional | QBJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253737) |
| February 3, 2026 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | California | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253701) |
| January 23, 2026 | P160007/S058 | MiniMed Go app; Simplera sensor | Medtronic Minimed | California | Approved | PMA real-time process supplement | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S058) |
| January 21, 2026 | K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | SHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251281) |
| January 15, 2026 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | California | Substantially Equivalent | 510(k) traditional | QFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253470) |
| January 14, 2026 | K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | California | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253585) |
| January 9, 2026 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | De Novo (dual track) | CGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252206) |
| January 9, 2026 | K251157 | Core Metabolic | Truvian Health | California | Substantially Equivalent | 510(k) traditional | CIX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251157) |
| January 6, 2026 | K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PDJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252749) |
| December 30, 2025 | K251091 | Lipids | Truvian Health | California | Substantially Equivalent | 510(k) traditional | CHH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251091) |
| December 23, 2025 | K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | Texas | Substantially Equivalent | 510(k) traditional | JMT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251800) |
| December 19, 2025 | K251152 | DBLG2 | Diabeloop | France | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251152) |
| December 19, 2025 | K251074 | Tru Liver Health Test Panel | Truvian Health | California | Substantially Equivalent | 510(k) traditional | CJE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251074) |
| December 18, 2025 | P160017/S133 | MiniMed 670G System | Medtronic Minimed, Inc. | California | Approved | PMA 180-day supplement | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S133) |
| December 17, 2025 | K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM)... | Dexcom, Inc. | California | Substantially Equivalent | 510(k) special | QBJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253710) |
| December 11, 2025 | P160017/S125 | MiniMed 780G System | Medtronic Minimed, Inc. | California | Approved | PMA panel track supplement | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S125) |
| December 10, 2025 | P250012/S005 | Simplera Sync Sensor; Guardian 4 Sensor | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S005) |
| December 10, 2025 | P160017/S131 | MiniMed 670G system MiniMed 770G system MiniMed 780G system | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S131) |
| December 8, 2025 | P250012/S007 | Simplera Sync Sensor | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S007) |
| December 8, 2025 | P160017/S134 | MiniMed 780G System | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S134) |
| December 8, 2025 | P160007/S059 | Simplera System | Medtronic Minimed | California | 30-day notice accepted | PMA 30-day notice | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S059) |
| December 5, 2025 | P250012/S006 | Simplera Sync Sensor | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | SFI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012S006) |
| December 5, 2025 | P160017/S132 | MiniMed 780G System | Medtronic Minimed, Inc. | California | 30-day notice accepted | PMA 30-day notice | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S132) |
| December 5, 2025 | P160007/S057 | Simplera System | Medtronic Minimed | California | 30-day notice accepted | PMA 30-day notice | MDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160007S057) |
| December 3, 2025 | K251779 | Omnipod 5 algorithm | Insulet Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251779) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic Minimed, Inc. | 37 | September 29, 2026 |
| Medtronic Minimed | 13 | July 21, 2026 |
| Dexcom, Inc. | 8 | August 11, 2026 |
| Becton, Dickinson and Company | 7 | October 16, 2026 |
| Beckman Coulter, Inc. | 6 | October 20, 2026 |
| Beta Bionics, Inc. | 5 | October 21, 2026 |
| Roche Diagnostics | 5 | June 12, 2026 |
| Radiometer Medicals Aps | 5 | May 1, 2026 |
| Tandem Diabetes Care, Inc. | 5 | April 24, 2026 |
| Abbott Diabetes Care, Inc. | 4 | September 1, 2026 |
| Abbott Point of Care, Inc. | 4 | June 26, 2026 |
| Truvian Health | 4 | January 9, 2026 |
| Siemens Healthcare Diagnostics, Inc. | 3 | February 27, 2026 |
| Nova Biomedical Corporation | 3 | January 21, 2026 |
| CMT Health PTE., Ltd. | 2 | October 28, 2026 |
| Sol-Millennium Medical, Inc. | 2 | October 21, 2026 |
| Biolinq Incorporated | 2 | September 18, 2026 |
| Insulet Corporation | 2 | June 29, 2026 |
| Advanced Breath Diagnostics | 2 | April 24, 2026 |
| Miracell Co., Ltd. | 2 | April 2, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 101 | October 28, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 33 | September 1, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 15 | October 30, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 10 | September 29, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 5 | June 12, 2026 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 4 | June 12, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 3 | December 11, 2025 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 2 | August 25, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 2 | June 18, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 1 | October 2, 2025 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 84 | October 21, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 14 | October 30, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 11 | October 16, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 7 | June 29, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 5 | June 12, 2026 |
| [Denmark](https://specstream.ai/data/fda-clearances/country/denmark) | 5 | May 1, 2026 |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 4 | October 20, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 4 | October 2, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 4 | September 16, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 4 | August 27, 2026 |
| [Delaware](https://specstream.ai/data/fda-clearances/state/delaware) | 4 | February 27, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 3 | October 23, 2026 |
| [New Hampshire](https://specstream.ai/data/fda-clearances/state/new-hampshire) | 3 | October 15, 2026 |
| [Singapore](https://specstream.ai/data/fda-clearances/country/singapore) | 2 | October 28, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 2 | October 21, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 2 | July 23, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 2 | April 24, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 2 | March 19, 2026 |
| [Ireland](https://specstream.ai/data/fda-clearances/country/ireland) | 2 | October 24, 2025 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 2 | October 3, 2025 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 1 | September 8, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 1 | September 1, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 1 | June 18, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 1 | April 24, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 1 | December 23, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).