Data / FDA device clearances / Illinois
FDA device clearances in Illinois: 225 since Nov 2024
The full list. FDA device clearances for applicants in Illinois: 225 rows for $11.25, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 8 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/illinois, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 29, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 225 device decisions for applicants in Illinois from November 12, 2024 to October 29, 2026: 126 510(k) clearances and De Novo grants and 99 PMA approvals and supplements, for 55 applicants. The newest, P230040/S030 on October 29, 2026, is Cordella Pulmonary Artery Sensor System from Endotronix, Inc..
The request: Every new FDA device clearance or approval for a company in Illinois, with its address, the device and the product code. $10 of credit on sign-up, no card.
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.
- 225Decisions
- 126510(k) and De Novo
- 99PMA
- October 29, 2026Latest decision
Newest decisions
The newest 100 of 225, 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 29, 2026 | P230040/S030 | Cordella Pulmonary Artery Sensor System | Endotronix, Inc. | Illinois | Approved | PMA 180-day supplement | MOM | accessdata.fda.gov |
| October 23, 2026 | P210011/S006 | xT CDx | Tempus AI, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| October 23, 2026 | K260421 | LuxDesign | LuxCreo, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | PNN | accessdata.fda.gov |
| 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 |
| October 20, 2026 | P230040/S035 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| October 20, 2026 | DEN260027 | Elecsys HBsAg II quant II RxDx | Roche Diagnostics | Illinois | Unknown | De Novo | SJM | accessdata.fda.gov |
| October 16, 2026 | P230040/S031 | Cordelia Pulmonary Artery Pressure Sensor System (CorPASS) | Endotronix, Inc. | Illinois | Approved | PMA real-time process supplement | MOM | accessdata.fda.gov |
| October 14, 2026 | P230040/S034 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| September 25, 2026 | P230040/S033 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| September 25, 2026 | K260023 | TumorSight Risk | SimBioSys, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | SHW | accessdata.fda.gov |
| September 25, 2026 | K254297 | Tempus ECG-MR | Tempus AI, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | SBQ | accessdata.fda.gov |
| September 23, 2026 | K262156 | Anti-HCV Next | Abbott Laboratories | Illinois | Substantially Equivalent | 510(k) traditional | MZO | accessdata.fda.gov |
| September 18, 2026 | K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | Illinois | Substantially Equivalent | 510(k) traditional | LGZ | accessdata.fda.gov |
| September 11, 2026 | K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | Illinois | Substantially Equivalent | 510(k) abbreviated | FPA | accessdata.fda.gov |
| September 10, 2026 | K262202 | Cerasmart Forte | GC America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | EBF | accessdata.fda.gov |
| September 10, 2026 | K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | Illinois | Substantially Equivalent | 510(k) special | DXN | accessdata.fda.gov |
| September 2, 2026 | P230003/S019 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| September 2, 2026 | P210011/S002 | xT CDx | Tempus AI, Inc. | Illinois | Approved | PMA 180-day supplement | PQP | accessdata.fda.gov |
| September 2, 2026 | K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | Illinois | Substantially Equivalent | 510(k) traditional | LZA | accessdata.fda.gov |
| August 25, 2026 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | FMF | accessdata.fda.gov |
| August 21, 2026 | K253699 | Tempus ECG-PH | Tempus AI, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | SAT | accessdata.fda.gov |
| August 13, 2026 | P230040/S032 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| August 11, 2026 | K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | QPC | accessdata.fda.gov |
| August 7, 2026 | P210036/S009 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | Illinois | Approved | PMA 135-day supplement | LMG | accessdata.fda.gov |
| August 7, 2026 | P210036/S008 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | Illinois | Approved | PMA 135-day supplement | LMG | accessdata.fda.gov |
| July 29, 2026 | K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | Illinois | Substantially Equivalent | 510(k) traditional | DYB | accessdata.fda.gov |
| July 28, 2026 | K261430 | TruLift Expandable System | Life Spine, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | MAX | accessdata.fda.gov |
| July 23, 2026 | P230003/S015 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| July 15, 2026 | P830063/S032 | PRISMAFLEX TPE2000 SET | Vantive US Healthcare, LLC | Illinois | 30-day notice accepted | PMA 30-day notice | MDP | accessdata.fda.gov |
| July 14, 2026 | K253662 | LIXI (LXOSFM1) | Luwi, LLC | Illinois | Substantially Equivalent | 510(k) traditional | MSC | accessdata.fda.gov |
| July 6, 2026 | K253317 | Cytrans Elashield | GC America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | LYC | accessdata.fda.gov |
| June 22, 2026 | P230003/S018 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| June 22, 2026 | K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | Illinois | Substantially Equivalent | 510(k) traditional | DXQ | accessdata.fda.gov |
| June 18, 2026 | K261246 | SRGC-06 | GC America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | EBF | accessdata.fda.gov |
| June 18, 2026 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | FMF | accessdata.fda.gov |
| June 11, 2026 | K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | IOR | accessdata.fda.gov |
| June 8, 2026 | P230003/S014 | Alinity m HR HPV Assay | Abbott Molecular, Inc. | Illinois | Approved | PMA real-time process supplement | MAQ | accessdata.fda.gov |
| June 8, 2026 | P210036/S007 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | Illinois | Approved | PMA 180-day supplement | LMG | accessdata.fda.gov |
| June 5, 2026 | K251684 | Alma TED+ System | Alma Lasers, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | OAP | accessdata.fda.gov |
| June 2, 2026 | K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| May 28, 2026 | P230003/S017 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| May 28, 2026 | P210011/S004 | xT CDx | Tempus AI, Inc. | Illinois | Approved | PMA 180-day supplement | PQP | accessdata.fda.gov |
| May 28, 2026 | P170041/S009 | Abbott RealTime IDH1 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | accessdata.fda.gov |
| May 28, 2026 | P170005/S006 | Abbott RealTime IDH2 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | accessdata.fda.gov |
| May 27, 2026 | K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | GKZ | accessdata.fda.gov |
| May 22, 2026 | DEN250057 | PCWP Analysis Software | Cardiosense, Inc. | Illinois | Unknown | De Novo | SIF | accessdata.fda.gov |
| May 19, 2026 | P230003/S016 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| May 19, 2026 | K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | Illinois | Substantially Equivalent | 510(k) traditional | PCH | accessdata.fda.gov |
| May 18, 2026 | K254109 | G-CEM UNIVERSAL | GC America, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | EMA | accessdata.fda.gov |
| May 18, 2026 | K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | Illinois | Substantially Equivalent | 510(k) traditional | EZD | accessdata.fda.gov |
| May 15, 2026 | P230003/S013 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | Approved | PMA real-time process supplement | MAQ | accessdata.fda.gov |
| May 12, 2026 | K260837 | VersaLift Expandable System | Life Spine, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | MAX | accessdata.fda.gov |
| May 11, 2026 | P120008/S032 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | LOK | accessdata.fda.gov |
| April 28, 2026 | K253243 | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | Illinois | Substantially Equivalent | 510(k) abbreviated | FYA | accessdata.fda.gov |
| April 28, 2026 | K252424 | Anti-HCV Next | Abbott Laboratories | Illinois | Substantially Equivalent | 510(k) traditional | MZO | accessdata.fda.gov |
| April 21, 2026 | K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | FDS | accessdata.fda.gov |
| April 16, 2026 | K254274 | ARx® SAI Implant System | Life Spine, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | NKB | accessdata.fda.gov |
| April 16, 2026 | K253260 | ORIO-3D Cage System | SpineCraft | Illinois | Substantially Equivalent | 510(k) traditional | ODP | accessdata.fda.gov |
| April 10, 2026 | K253510 | Freestyle Mini Hands-free | Medela, LLC | Illinois | Substantially Equivalent | 510(k) traditional | HGX | accessdata.fda.gov |
| April 7, 2026 | K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | Illinois | Substantially Equivalent | 510(k) traditional | LOL | accessdata.fda.gov |
| April 2, 2026 | K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | PHC | accessdata.fda.gov |
| April 1, 2026 | K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | HLZ | accessdata.fda.gov |
| March 25, 2026 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT /... | Medline Industries, LP | Illinois | Substantially Equivalent | 510(k) traditional | BZE | accessdata.fda.gov |
| March 20, 2026 | P170041/S008 | Abbott RealTime IDH1 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | accessdata.fda.gov |
| March 20, 2026 | P170005/S005 | Abbott RealTime IDH2 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | accessdata.fda.gov |
| March 13, 2026 | P830063/S030 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | Illinois | Approved | PMA real-time process supplement | MDP | accessdata.fda.gov |
| March 12, 2026 | P230003/S011 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | Approved | PMA real-time process supplement | MAQ | accessdata.fda.gov |
| March 4, 2026 | K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | Illinois | Substantially Equivalent | 510(k) traditional | KWQ | accessdata.fda.gov |
| March 2, 2026 | P230040/S029 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| February 26, 2026 | K253021 | ANNE Maternal | Sibel Health, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | HGM | accessdata.fda.gov |
| February 25, 2026 | K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | Illinois | Substantially Equivalent | 510(k) special | FQH | accessdata.fda.gov |
| February 25, 2026 | K251687 | Konig Bell Circumcision Clamp | Medline Industries, LP | Illinois | Substantially Equivalent | 510(k) traditional | HFX | accessdata.fda.gov |
| February 24, 2026 | P230040/S028 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| February 24, 2026 | P230003/S012 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| February 23, 2026 | P910007/S068 | ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTF | accessdata.fda.gov |
| February 20, 2026 | K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | Bd | Illinois | Substantially Equivalent | 510(k) traditional | FQH | accessdata.fda.gov |
| February 18, 2026 | P150041/S008 | Vysis CLL FISH Probe Kit | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | PNK | accessdata.fda.gov |
| February 18, 2026 | P110012/S023 | Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWE | accessdata.fda.gov |
| February 18, 2026 | P030052/S030 | UroVysion Bladder Cancer Kit | Abbott Molecular | Illinois | 30-day notice accepted | PMA 30-day notice | accessdata.fda.gov | |
| February 17, 2026 | P230040/S027 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| February 13, 2026 | P230040/S026 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | Approved | PMA special supplement | MOM | accessdata.fda.gov |
| February 13, 2026 | K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | Illinois | Substantially Equivalent | 510(k) traditional | HGX | accessdata.fda.gov |
| February 12, 2026 | P980007/S056 | ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTG | accessdata.fda.gov |
| February 12, 2026 | P910007/S067 | ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTF | accessdata.fda.gov |
| February 12, 2026 | P120008/S031 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | LOK | accessdata.fda.gov |
| February 10, 2026 | K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | Illinois | Substantially Equivalent | 510(k) special | QIH | accessdata.fda.gov |
| February 6, 2026 | K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | Illinois | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| January 23, 2026 | K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | MAX | accessdata.fda.gov |
| January 22, 2026 | K253498 | Pump In Style® Pro+ | Medela, LLC | Illinois | Substantially Equivalent | 510(k) special | HGX | accessdata.fda.gov |
| January 15, 2026 | DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. | Illinois | Unknown | De Novo | SGY | accessdata.fda.gov |
| January 14, 2026 | K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | Illinois | Substantially Equivalent | 510(k) traditional | LZC | accessdata.fda.gov |
| January 9, 2026 | P230040/S025 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | accessdata.fda.gov |
| January 8, 2026 | K253639 | View | GE Healthcare | Illinois | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| January 6, 2026 | P230003/S010 | Alinity m HR HPV | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| December 23, 2025 | P830063/S031 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | Illinois | 30-day notice accepted | PMA 30-day notice | MDP | accessdata.fda.gov |
| December 19, 2025 | P230040/S015 | CorPASS System | Endotronix, Inc. | Illinois | Approved | PMA 180-day supplement | MOM | accessdata.fda.gov |
| December 18, 2025 | P030039/S032 | Coseal Applicator Tips | Baxter Bio Science | Illinois | 30-day notice accepted | PMA 30-day notice | NBE | accessdata.fda.gov |
| December 16, 2025 | K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | QPC | accessdata.fda.gov |
| December 16, 2025 | K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | PPW | accessdata.fda.gov |
| December 16, 2025 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | Illinois | Substantially Equivalent | 510(k) traditional | DXQ | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 34 | September 2, 2026 |
| Endotronix, Inc. | 30 | October 29, 2026 |
| Abbott Laboratories | 16 | September 23, 2026 |
| Baxter Healthcare Corporation | 13 | August 7, 2026 |
| Medline Industries, LP | 11 | July 29, 2026 |
| Life Spine, Inc. | 9 | July 28, 2026 |
| Tempus AI, Inc. | 8 | October 23, 2026 |
| GC America, Inc. | 7 | September 10, 2026 |
| Sol-Millennium Medical, Inc. | 5 | October 21, 2026 |
| Vantive US Healthcare, LLC | 5 | July 15, 2026 |
| Icu Medical, Inc. | 5 | April 2, 2026 |
| Cardinalhealth | 4 | September 2, 2026 |
| Alma Lasers, Inc. | 4 | June 5, 2026 |
| Sysmex America, Inc. | 4 | May 27, 2026 |
| Abbott Molecular | 4 | February 18, 2026 |
| LuxCreo, Inc. | 3 | October 23, 2026 |
| Luminex Corporation | 3 | May 19, 2026 |
| EvoEndo, Inc. | 3 | April 21, 2026 |
| Medela, LLC | 3 | April 10, 2026 |
| Siemens Medical Solutions USA, Inc. | 3 | February 10, 2026 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Cardiovascular | 48 | October 29, 2026 |
| Microbiology | 40 | September 23, 2026 |
| General Hospital | 21 | September 18, 2026 |
| General, Plastic Surgery | 17 | August 11, 2026 |
| Gastroenterology, Urology | 16 | July 15, 2026 |
| Pathology | 12 | October 23, 2026 |
| Dental | 12 | October 23, 2026 |
| Orthopedic | 12 | July 28, 2026 |
| Immunology | 8 | May 11, 2026 |
| Radiology | 8 | February 10, 2026 |
| Obstetrics/Gynecology | 6 | July 14, 2026 |
| Medical Genetics | 5 | May 28, 2026 |
| Hematology | 4 | May 27, 2026 |
| Anesthesiology | 4 | March 25, 2026 |
| Neurology | 3 | June 2, 2026 |
| Clinical Chemistry | 2 | October 21, 2026 |
| Physical Medicine | 2 | June 11, 2026 |
| Ophthalmic | 2 | April 1, 2026 |
| Unknown | 1 | October 20, 2026 |
| Ear, Nose, Throat | 1 | August 11, 2025 |
| Clinical Toxicology | 1 | July 9, 2025 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 108 | October 23, 2026 |
| PMA 30-day notice | 69 | October 23, 2026 |
| PMA real-time process supplement | 14 | October 16, 2026 |
| 510(k) special | 13 | October 21, 2026 |
| PMA 180-day supplement | 9 | October 29, 2026 |
| PMA 135-day supplement | 4 | August 7, 2026 |
| De Novo | 3 | October 20, 2026 |
| 510(k) abbreviated | 2 | September 11, 2026 |
| PMA special supplement | 1 | February 13, 2026 |
| PMA panel track supplement | 1 | September 10, 2025 |
| PMA original approval | 1 | August 15, 2025 |
Where FDA publishes these decisions
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. Spot a wrong value? Write to [email protected] with the link to this page.