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Data / FDA device clearances / Washington

FDA device clearances in Washington: 107 since Nov 2024

The full list. FDA device clearances for applicants in Washington: 107 rows for $5.35, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 5 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/washington, 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 107 device decisions for applicants in Washington from November 15, 2024 to October 29, 2026: 61 510(k) clearances and De Novo grants and 46 PMA approvals and supplements, for 32 applicants. The newest, P160026/S076 on October 29, 2026, is LIFEPAK® 35 monitor/defibrillator from Physio-Control, Inc..

The request: Every new FDA device clearance or approval for a company in Washington, 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.

  • 107Decisions
  • 61510(k) and De Novo
  • 46PMA
  • October 29, 2026Latest decision

Newest decisions

The newest 100 of 107, 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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 29, 2026P160026/S076LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
October 1, 2026K260029Firstar Dental HandpiecesFDC Technology Industry Co.WashingtonSubstantially Equivalent510(k) traditionalEFBaccessdata.fda.gov
October 1, 2026K260027Firstar Dental Electric MotorFDC Technology Industry Co.WashingtonSubstantially Equivalent510(k) traditionalEBWaccessdata.fda.gov
September 28, 2026P200037/S021ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.Washington30-day notice acceptedPMA 30-day noticeMVKaccessdata.fda.gov
September 25, 2026K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
September 24, 2026P160026/S074LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15...Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
September 10, 2026P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
September 10, 2026K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.WashingtonSubstantially Equivalent510(k) specialOBJaccessdata.fda.gov
September 2, 2026P160026/S069LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
August 28, 2026P160026/S072Physio-Control LIFEPAK®35 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
August 20, 2026P180007/S016Spiration® Valve SystemGyrus Acmi, Inc.WashingtonApprovedPMA 180-day supplementNJKaccessdata.fda.gov
August 6, 2026P160026/S071LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
August 4, 2026K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
July 30, 2026P170018/S025LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
July 30, 2026P160026/S070LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15...Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
July 27, 2026K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
July 16, 2026P200037/S020ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)Kestra Medical Technologies, Inc.Washington30-day notice acceptedPMA 30-day noticeMVKaccessdata.fda.gov
June 29, 2026K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
June 26, 2026K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.WashingtonSubstantially Equivalent510(k) abbreviatedGXYaccessdata.fda.gov
June 25, 2026P160026/S068LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 16, 2026K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin...Siemens Medical Solutions USA, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
May 27, 2026K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
May 27, 2026K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
May 21, 2026P180028/S019HeartStart FRx Defibrillator (861304)Philips Medical SystemsWashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
May 21, 2026P160028/S007HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) DefibrillatorPhilips Medical Systems, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
May 7, 2026P180007/S015Spiration Valve System (SVS)Gyrus Acmi, Inc.Washington30-day notice acceptedPMA 30-day noticeNJKaccessdata.fda.gov
May 6, 2026P160026/S067LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
May 5, 2026K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
April 14, 2026P200037/S019ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.Washington30-day notice acceptedPMA 30-day noticeMVKaccessdata.fda.gov
March 27, 2026K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
March 10, 2026K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
March 6, 2026P200037/S018ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.WashingtonApprovedPMA 180-day supplementMVKaccessdata.fda.gov
March 5, 2026P160026/S066LIFEPAK 35 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
February 23, 2026P160026/S065LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
February 13, 2026K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)WashingtonSubstantially Equivalent510(k) traditionalDXHaccessdata.fda.gov
February 2, 2026P180028/S018HeartStart FRx DefibrillatorPhilips Medical SystemsWashington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
February 2, 2026P160029/S029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)Philips Medical Systems, Inc.Washington30-day notice acceptedPMA 30-day noticeNSAaccessdata.fda.gov
January 30, 2026K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxWashingtonSubstantially Equivalent510(k) traditionalPOKaccessdata.fda.gov
January 16, 2026K252960SOLIUS PRO UVB Light PanelSolius Labs, Inc.WashingtonSubstantially Equivalent510(k) traditionalSGZaccessdata.fda.gov
January 7, 2026K252507SmileInspectorAmv Consulting, LLCWashingtonSubstantially Equivalent510(k) traditionalPNNaccessdata.fda.gov
December 22, 2025K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
December 15, 2025K252950Paradigm SystemProprio, Inc.WashingtonSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
December 14, 2025K250851Hypnos (369054-200)Cadwell Industries, Inc.WashingtonSubstantially Equivalent510(k) traditionalOLZaccessdata.fda.gov
December 10, 2025K251598IntellidropBrainspace, Inc.WashingtonSubstantially Equivalent510(k) traditionalJXGaccessdata.fda.gov
December 4, 2025P160026/S063LIFEPAK® 35 Defibrillator/monitorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
November 21, 2025P160026/S064LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
November 17, 2025K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
November 13, 2025K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
November 6, 2025P170018/S023LIFEPAK® CR2 Automated External DefibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
November 3, 2025K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
October 14, 2025P160026/S062LIFEPAK 1000 defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
October 14, 2025K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.WashingtonSubstantially Equivalent510(k) specialMPDaccessdata.fda.gov
October 12, 2025K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.WashingtonSubstantially Equivalent510(k) traditionalQYTaccessdata.fda.gov
October 9, 2025K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
September 29, 2025P170018/S024LIFEPACK® CR2 Automated External Defibrillator (AED)Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
September 25, 2025K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical TechnologiesWashingtonSubstantially Equivalent510(k) traditionalJKAaccessdata.fda.gov
September 22, 2025K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemSurgical Principals, Inc.WashingtonSubstantially Equivalent510(k) traditionalGCJaccessdata.fda.gov
September 18, 2025K251597InnerView SystemPerimetrics, Inc.WashingtonSubstantially Equivalent510(k) traditionalEKXaccessdata.fda.gov
September 5, 2025P180028/S017HeartStart FRx Defibrillator and HeartStart SMART Pads IIPhilips Medical SystemsWashington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
August 29, 2025K252019CurvaFix Low Profile SystemCurvafix, Inc.WashingtonSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
August 29, 2025K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
August 20, 2025K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON...Siemens Medical Solutions USA, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
July 24, 2025K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
July 22, 2025P200037/S017ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.Washington30-day notice acceptedPMA 30-day noticeMVKaccessdata.fda.gov
July 18, 2025K252218MF SC GEN2 Facial Toning SystemMicro Current Technology, Inc.WashingtonSubstantially Equivalent510(k) specialNFOaccessdata.fda.gov
July 10, 2025K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
June 30, 2025P160026/S061LIFEPAK FLEX™ Lithium-ion BatteryPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 20, 2025P170018/S022LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 20, 2025P160029/S028HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)Philips Medical Systems, Inc.Washington30-day notice acceptedPMA 30-day noticeNSAaccessdata.fda.gov
June 20, 2025P160026/S060LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor...Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 20, 2025P160026/S059LIFEPAK 35 monitor/defibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 18, 2025K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
June 9, 2025P180028/S016HeartStart FRx Defibrillator (861304)Philips Medical SystemsWashington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
June 9, 2025P160029/S027HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)Philips Medical Systems, Inc.Washington30-day notice acceptedPMA 30-day noticeNSAaccessdata.fda.gov
June 4, 2025K250879Paradigm SystemProprio, Inc.WashingtonSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
May 21, 2025K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
May 16, 2025K241581Hemodialysis CatheterHaolang Medical USA CorporationWashingtonUnknown510(k) traditionalMSDaccessdata.fda.gov
May 15, 2025K242519Lumify Diagnostic Ultrasound SystemPhilips UltrasoundWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
May 9, 2025P180028/S015HeartStart FRx DefibrillatorPhilips Medical SystemsWashingtonApprovedPMA special supplementMKJaccessdata.fda.gov
May 9, 2025P160028/S006HeartStart FR3 DefibrillatorPhilips Medical Systems, Inc.WashingtonApprovedPMA special supplementMKJaccessdata.fda.gov
May 9, 2025K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) specialIYNaccessdata.fda.gov
May 8, 2025K242670Lumify Diagnostic Ultrasound SystemPhilips UltrasoundWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
April 28, 2025K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
April 25, 2025P200037/S016ASSURE Wearable Cardioverter Defibrillator (WCD) SystemKestra Medical Technologies, Inc.Washington30-day notice acceptedPMA 30-day noticeMVKaccessdata.fda.gov
April 25, 2025K242321KosmosEchoNous, Inc.WashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
April 24, 2025K233337Freespira Breathing SystemFreespira, Inc.WashingtonSubstantially Equivalent510(k) traditionalSENaccessdata.fda.gov
April 18, 2025P050048/S010MONOLISA ANTI-HBS EIABio-Rad LaboratoriesWashington30-day notice acceptedPMA 30-day noticeLOMaccessdata.fda.gov
April 18, 2025K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCWashingtonSubstantially Equivalent510(k) traditionalDCKaccessdata.fda.gov
April 10, 2025K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
April 3, 2025P160026/S057LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15...Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
March 20, 2025K242958Joylux Intimacy Gel (PG3100)Joylux, Inc.WashingtonSubstantially Equivalent510(k) traditionalNUCaccessdata.fda.gov
March 17, 2025P160026/S053LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.WashingtonApprovedPMA real-time process supplementMKJaccessdata.fda.gov
February 21, 2025K243258Paradigm SystemProprio, Inc.WashingtonSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
February 10, 2025K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
February 6, 2025K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCWashingtonSubstantially Equivalent510(k) traditionalIYNaccessdata.fda.gov
February 3, 2025P160026/S056LIFEPAK® 1000 DefibrillatorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
January 31, 2025P160026/S055LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15...Physio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
January 27, 2025P160026/S054LIFEPAK® 15 monitorPhysio-Control, Inc.Washington30-day notice acceptedPMA 30-day noticeMKJaccessdata.fda.gov
January 27, 2025K231297Firstar Dental UnitFirstar Dental CompanyWashingtonSubstantially Equivalent510(k) traditionalEIAaccessdata.fda.gov
January 23, 2025K241819CephNinjaCyncronus, LLCWashingtonSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Physio-Control, Inc.27October 29, 2026
Philips Ultrasound, LLC20September 25, 2026
Siemens Medical Solutions USA, Inc.7September 10, 2026
Kestra Medical Technologies, Inc.6September 28, 2026
Philips Medical Systems, Inc.6May 21, 2026
Philips Medical Systems5May 21, 2026
FUJIFILM Sonosite, Inc.4March 10, 2026
Cadwell Industries, Inc.3June 26, 2026
Proprio, Inc.3December 15, 2025
FDC Technology Industry Co.2October 1, 2026
Gyrus Acmi, Inc.2August 20, 2026
Philips Ultrasound2May 15, 2025
Measure Labs, Inc. (Dba Preemptiveai, Inc.)1February 13, 2026
Precision Medical Ventures, Inc. Dba Revealdx1January 30, 2026
Solius Labs, Inc.1January 16, 2026
Amv Consulting, LLC1January 7, 2026
Brainspace, Inc.1December 10, 2025
InBios International, Inc.1October 12, 2025
Magnolia Medical Technologies1September 25, 2025
Surgical Principals, Inc.1September 22, 2025

By panel

PanelDecisionsLatest
Cardiovascular47October 29, 2026
Radiology35September 25, 2026
Neurology8June 26, 2026
Dental5October 1, 2026
Anesthesiology3August 20, 2026
Microbiology2October 12, 2025
Gastroenterology, Urology2September 22, 2025
General, Plastic Surgery1January 16, 2026
Clinical Chemistry1September 25, 2025
Orthopedic1August 29, 2025
Immunology1April 18, 2025
Obstetrics/Gynecology1March 20, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional51October 1, 2026
PMA 30-day notice33October 29, 2026
510(k) special9September 10, 2026
PMA real-time process supplement9September 2, 2026
PMA 180-day supplement2August 20, 2026
PMA special supplement2May 9, 2025
510(k) abbreviated1June 26, 2026

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.