Data / FDA device clearances / Microbiology

FDA Microbiology device clearances: 377 since Nov 2024

Name: FDA microbiology device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA microbiology device clearances and approvals: 377 rows for $18.85, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 11 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 6 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/panel/microbiology, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 377 device decisions in microbiology (FDA review panel) from November 15, 2024 to October 30, 2026: 218 510(k) clearances and De Novo grants and 159 PMA approvals and supplements, for 107 applicants. The newest, K263232 on October 30, 2026, is eplex RP3 Control M530; eplex RP3 Negative from Maine Molecular Quality Controls, Inc..

The request: Every new FDA clearance or approval of a microbiology device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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377Decisions
218510(k) and De Novo
159PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 377, 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	K263232	eplex RP3 Control M530; eplex RP3 Negative	Maine Molecular Quality Controls, Inc.	Maine	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
October 30, 2026	K262938	cobas eplex respiratory pathogen panel 3	GenMark Diagnostics, Inc.	California	Substantially Equivalent	510(k) traditional	QOF	accessdata.fda.gov
October 27, 2026	P190028/S026	cobas® HPV	Roche Molecular Systems, Inc.	California	30-day notice accepted	PMA 30-day notice	MAQ	accessdata.fda.gov
October 27, 2026	P100020/S066	cobas® HPV	Roche Molecular Systems, Inc.	California	30-day notice accepted	PMA 30-day notice	MAQ	accessdata.fda.gov
October 27, 2026	K261379	BD Veritor System for SARS-CoV-2	BD Diagnostic Solutions / Becton, Dickinson & Company	Maryland	Substantially Equivalent	De Novo (dual track)	QVF	accessdata.fda.gov
October 23, 2026	K260302	B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC	B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)	Germany	Substantially Equivalent	510(k) traditional	SJQ	accessdata.fda.gov
October 22, 2026	K263333	Xpert Xpress CoV-2/Flu plus	Cepheid®	California	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
October 21, 2026	K262573	SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control	Maine Molecular Quality Controls, Inc.	Maine	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
October 21, 2026	K262136	BIOFIRE SPOTFIRE Vaginitis (VG) Panel	Biofire Diagnostics, LLC	Utah	Substantially Equivalent	De Novo (dual track)	PQA	accessdata.fda.gov
October 21, 2026	K261347	DASH Flu A/B Test	Nuclein, LLC	Texas	Substantially Equivalent	De Novo (dual track)	OCC	accessdata.fda.gov
October 19, 2026	K261109	Access MeMed BV	Beckman Coulter, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	QPS	accessdata.fda.gov
October 14, 2026	P010033/S053	QuantiFERON-TB Gold Plus Test	Qiagen	Maryland	30-day notice accepted	PMA 30-day notice	NCD	accessdata.fda.gov
October 14, 2026	K262432	CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid...	CorDx, Inc.	Georgia	Substantially Equivalent	510(k) traditional	SCA	accessdata.fda.gov
October 7, 2026	K262368	B. anthracis Real-time PCR Assay	Centers for Disease Control and Prevention	Georgia	Substantially Equivalent	510(k) traditional	NHT	accessdata.fda.gov
October 2, 2026	K263120	Xpert Xpress CoV-2/Flu plus	Cepheid®	California	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
October 2, 2026	K260233	Elecsys EBV IgM	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LJN	accessdata.fda.gov
October 2, 2026	K260232	Elecsys EBV VCA IgG	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LSE	accessdata.fda.gov
October 2, 2026	K260221	Elecsys EBV EBNA IgG	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LSE	accessdata.fda.gov
October 1, 2026	K260283	VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)	bioMerieux, Inc.	Missouri	Substantially Equivalent	510(k) traditional	LON	accessdata.fda.gov
September 30, 2026	K263035	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A...	Centers for Disease Control and Prevention	Georgia	Substantially Equivalent	510(k) special	OZE	accessdata.fda.gov
September 28, 2026	K260619	VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)	Biomérieux, Inc.	Missouri	Substantially Equivalent	510(k) traditional	LON	accessdata.fda.gov
September 25, 2026	K261336	Xpert Respiratory Panel	Cepheid	California	Substantially Equivalent	510(k) traditional	QOF	accessdata.fda.gov
September 24, 2026	P180047/S046	LIAISON® QuantiFERON®-TB Gold Plus II.	DiaSorin, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NCD	accessdata.fda.gov
September 24, 2026	K262168	QIAstat-Dx BCID GN Plus AMR Panel	QIAGEN GmbH	Germany	Substantially Equivalent	510(k) traditional	PEN	accessdata.fda.gov
September 23, 2026	K262156	Anti-HCV Next	Abbott Laboratories	Illinois	Substantially Equivalent	510(k) traditional	MZO	accessdata.fda.gov
September 22, 2026	K263054	BIOFIRE Respiratory Panel 2.1 (RP2.1)	Biofire Diagnostics	Utah	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
September 14, 2026	K262163	BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth	Becton Dickinson and Company	Maryland	Substantially Equivalent	510(k) traditional	JTZ	accessdata.fda.gov
September 11, 2026	K261837	FINDER Flu A&B/SARS-CoV-2 Test	Baebies, Inc.	North Carolina	Substantially Equivalent	510(k) traditional	QOF	accessdata.fda.gov
September 4, 2026	K254264	Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	California	Substantially Equivalent	De Novo (dual track)	QVF	accessdata.fda.gov
September 4, 2026	K254262	Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA	Ortho Clinical Diagnostics Inc. (QuidelOrtho)	California	Substantially Equivalent	De Novo (dual track)	PSZ	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
August 31, 2026	K262747	ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0	Abbott Diagnostics Scarborough, Inc.	Maine	Substantially Equivalent	510(k) special	OCC	accessdata.fda.gov
August 28, 2026	K260047	cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control...	Roche Molecular Systems, Inc.	California	Substantially Equivalent	510(k) traditional	PGX	accessdata.fda.gov
August 28, 2026	K260045	cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and...	Roche Molecular Systems, Inc.	California	Substantially Equivalent	510(k) traditional	OZN	accessdata.fda.gov
August 27, 2026	P180047/S045	LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus...	DiaSorin, Inc.	Minnesota	Approved	PMA real-time process supplement	NCD	accessdata.fda.gov
August 27, 2026	P180047/S043	LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold...	DiaSorin, Inc.	Minnesota	Approved	PMA 180-day supplement	NCD	accessdata.fda.gov
August 20, 2026	K262113	HardyDisk AST Tebipenem 10µg (TBP10)	Hardy Diagnostics	California	Substantially Equivalent	510(k) traditional	JTN	accessdata.fda.gov
August 19, 2026	P160037/S027	BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 444074)	Becton, Dickinson and Company	Maryland	Approved	PMA 180-day supplement	MAQ	accessdata.fda.gov
August 18, 2026	P220034/S010	LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus	DiaSorin, Inc.	Minnesota	Approved	PMA 180-day supplement	MYL	accessdata.fda.gov
August 14, 2026	P160037/S028	BD Onclarity HPV Assay	Becton, Dickinson and Company	Maryland	Approved	PMA real-time process supplement	MAQ	accessdata.fda.gov
August 7, 2026	K253453	Metrix COVID Test; Metrix COVID Test Pro	Aptitude Medical Systems, Inc.	California	Substantially Equivalent	510(k) traditional	QWB	accessdata.fda.gov
August 6, 2026	K254194	QIAstat-Dx BCID GPF Plus AMR Panel	QIAGEN GmbH	Germany	Substantially Equivalent	510(k) traditional	PAM	accessdata.fda.gov
July 24, 2026	K261781	Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60	Thermo Fisher Scientific (Oxoid Ltd.)	United Kingdom	Substantially Equivalent	510(k) traditional	JTN	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 23, 2026	K261853	Gepotidacin GEP 10 µg	Liofilchem, Inc.	Massachusetts	Substantially Equivalent	510(k) traditional	JTN	accessdata.fda.gov
July 17, 2026	K261475	BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit	Biofire Defense, LLC	Utah	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
July 16, 2026	K260021	cobas® BV/CV	Roche Molecular Systems, Inc.	California	Substantially Equivalent	510(k) traditional	PQA	accessdata.fda.gov
July 10, 2026	K261212	Flowflex Plus RSV + Flu A/B + COVID Rapid Test	ACON Laboratories, Inc.	California	Substantially Equivalent	De Novo (dual track)	SCA	accessdata.fda.gov
July 10, 2026	K254295	Sofia Lyme FIA; Sofia 2 Campylobacter FIA	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	California	Substantially Equivalent	510(k) traditional	LSR	accessdata.fda.gov
July 8, 2026	K260917	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800...	Roche Molecular Systems, Inc.	California	Substantially Equivalent	510(k) traditional	QEP	accessdata.fda.gov
July 8, 2026	K260160	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System	bioMerieux, Inc.	Missouri	Substantially Equivalent	510(k) traditional	SAN	accessdata.fda.gov
July 2, 2026	K261867	Xpert Carba-R	Cepheid®	California	Substantially Equivalent	510(k) special	POC	accessdata.fda.gov
June 26, 2026	K253316	PhAST instrument and PhAST Blood Culture Gram-negative Panel	Phast Corp.	Massachusetts	Substantially Equivalent	510(k) traditional	SAN	accessdata.fda.gov
June 24, 2026	P250039/S001	LIAISON® Biotrin Parvovirus B19 IgM Plus, LIAISON® Biotrin Control Parvovirus B19 IgM Plus	DiaSorin, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MYM	accessdata.fda.gov
June 24, 2026	P220034/S011	LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus	DiaSorin, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MYL	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 16, 2026	P190028/S023	cobas HPV	Roche Molecular Systems, Inc.	California	Approved	PMA 180-day supplement	MAQ	accessdata.fda.gov
June 15, 2026	K260333	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit	Diasorin Molecular, LLC	California	Substantially Equivalent	De Novo (dual track)	PGX	accessdata.fda.gov
June 12, 2026	K252932	Fast PCR Mini Respiratory Panel	Autonomous Medical Devices Incorporated	California	Substantially Equivalent	De Novo (dual track)	QOF	accessdata.fda.gov
June 10, 2026	K254121	Colli-PeeDx Urine Collection Kit	DNA Genotek, Inc.	Canada	Substantially Equivalent	510(k) traditional	SIH	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 5, 2026	K260754	Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test	Assure Tech., LLC	Delaware	Substantially Equivalent	510(k) traditional	QYT	accessdata.fda.gov
June 4, 2026	K260770	LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX	DiaSorin, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	LOM	accessdata.fda.gov
June 1, 2026	K253882	CorDx Tyfast COVID-19 Ag Rapid Test Rx	CorDx, Inc.	Georgia	Substantially Equivalent	De Novo (dual track)	QVF	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	K260213	BD BACTEC FXI Culture System	BD Diagnostic Systems	Maryland	Substantially Equivalent	510(k) traditional	MDB	accessdata.fda.gov
May 27, 2026	K253971	Visby Medical Flu and COVID-19 Test	Visby Medical, Inc.	California	Substantially Equivalent	510(k) traditional	SIA	accessdata.fda.gov
May 26, 2026	P180047/S044	LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON...	DiaSorin, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NCD	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	K260577	FilmArray TF Control Panel M527	Maine Molecular Quality Controls, Inc.	Maine	Substantially Equivalent	510(k) traditional	PMN	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 15, 2026	P230003/S013	Alinity m HR HPV	Abbott Molecular, Inc.	Illinois	Approved	PMA real-time process supplement	MAQ	accessdata.fda.gov
May 15, 2026	K253759	cobas liat CT/NG/MG nucleic acid test	Roche Molecular Systems, Inc.	California	Substantially Equivalent	De Novo (dual track)	QEP	accessdata.fda.gov
May 15, 2026	K253756	cobas liat CT/NG nucleic acid test	Roche Molecular Systems, Inc.	California	Substantially Equivalent	De Novo (dual track)	QEP	accessdata.fda.gov
May 11, 2026	K260842	HardyDisk AST Gepotidacin 10µg (GEP10)	Hardy Diagnostics	California	Substantially Equivalent	510(k) traditional	JTN	accessdata.fda.gov
May 7, 2026	P250039	LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus	DiaSorin, Inc.	Minnesota	Approved	PMA original approval	MYM	accessdata.fda.gov
May 1, 2026	K254139	BioCode® Respiratory Pathogen Panel (RPP)	Applied BioCode, Inc.	California	Substantially Equivalent	510(k) traditional	OCC	accessdata.fda.gov
April 30, 2026	K260342	AllTest Strep A Rapid Test	Hangzhou AllTest Biotech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GTY	accessdata.fda.gov
April 28, 2026	K252424	Anti-HCV Next	Abbott Laboratories	Illinois	Substantially Equivalent	510(k) traditional	MZO	accessdata.fda.gov
April 23, 2026	P190028/S024	cobas® HPV	Roche Molecular Systems, Inc.	California	Approved	PMA real-time process supplement	MAQ	accessdata.fda.gov
April 21, 2026	K260447	ETEST Gepotidacin (GEP) (0.016-256 µg/mL)	bioMérieux SA	France	Substantially Equivalent	510(k) traditional	JWY	accessdata.fda.gov
April 17, 2026	K260696	MTS Gepotidacin 0.016-256 µg/mL	Liofilchem s.r.l.	Italy	Substantially Equivalent	510(k) traditional	JWY	accessdata.fda.gov
April 15, 2026	K260282	VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance	bioMerieux, Inc.	Missouri	Substantially Equivalent	510(k) traditional	LON	accessdata.fda.gov
April 15, 2026	K253573	ASTar BC G- Kit	Q-Linea AB	Sweden	Substantially Equivalent	510(k) traditional	SAN	accessdata.fda.gov
April 13, 2026	K260095	Heal-Check Rapid COVID-19 Antigen Self-Test	Healgen Scientific,, LLC	Texas	Substantially Equivalent	510(k) traditional	QYT	accessdata.fda.gov
April 13, 2026	K252280	Elecsys Anti-SARS-CoV-2 S	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	QVP	accessdata.fda.gov
April 7, 2026	K260049	Elecsys Anti-HBc IgM	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	SEI	accessdata.fda.gov
April 7, 2026	K260048	Elecsys Anti-HAV IgM	Roche Diagnostics	Illinois	Substantially Equivalent	510(k) traditional	LOL	accessdata.fda.gov
April 7, 2026	K260046	Elecsys Anti-HBc II	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	SEI	accessdata.fda.gov
April 2, 2026	P160037/S025	BD Onclarity HPV Assay	Becton, Dickinson and Company	Maryland	Approved	PMA 180-day supplement	MAQ	accessdata.fda.gov
April 2, 2026	P160037/S024	BD Onclarity HPV Assay	Becton, Dickinson and Company	Maryland	Approved	PMA 180-day supplement	MAQ	accessdata.fda.gov
April 2, 2026	K260184	Onclarity Self-Collection Kit	Becton, Dickinson and Company	Maryland	Substantially Equivalent	510(k) traditional	SEP	accessdata.fda.gov
March 30, 2026	K252269	FINDER Flu A&B/SARS-CoV-2 Test	Baebies, Inc.	North Carolina	Substantially Equivalent	De Novo (dual track)	QOF	accessdata.fda.gov
March 27, 2026	K260041	MDx-Chex for BCP	Streck, LLC	Nebraska	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
March 26, 2026	K260281	VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)	Biomerieux	Missouri	Substantially Equivalent	510(k) traditional	LON	accessdata.fda.gov
March 24, 2026	K260787	FebriDx Bacterial/Non-bacterial Assay	Lumos Diagnostics, Inc.	California	Substantially Equivalent	De Novo (dual track)	QXA	accessdata.fda.gov
March 23, 2026	K254166	MDx-Chex for BCN	Streck	Nebraska	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
March 17, 2026	P190028/S025	cobas® HPV	Roche Molecular Systems, Inc.	California	30-day notice accepted	PMA 30-day notice	MAQ	accessdata.fda.gov
March 17, 2026	P100020/S065	cobas® HPV	Roche Molecular Systems, Inc.	California	30-day notice accepted	PMA 30-day notice	MAQ	accessdata.fda.gov
March 17, 2026	K254167	MDx-Chex for BCY	Streck, LLC	Nebraska	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
DiaSorin, Inc.	63	September 24, 2026
Roche Molecular Systems, Inc.	32	October 27, 2026
Abbott Molecular, Inc.	26	September 2, 2026
Becton, Dickinson and Company	15	August 19, 2026
Thermo Fisher Scientific	13	September 25, 2025
Beckman Coulter, Inc.	11	October 19, 2026
Roche Diagnostics	11	October 2, 2026
Cepheid®	9	October 22, 2026
QIAGEN GmbH	7	September 24, 2026
Abbott Laboratories	7	September 23, 2026
Roche Diagnostics Corp.	7	May 22, 2025
Hologic, Inc.	6	October 7, 2025
bioMerieux, Inc.	5	October 1, 2026
Hardy Diagnostics	5	August 20, 2026
Siemens Healthcare Diagnostics, Inc.	5	October 17, 2025
Maine Molecular Quality Controls, Inc.	4	October 30, 2026
Biofire Diagnostics, LLC	4	October 21, 2026
Centers for Disease Control and Prevention	4	October 7, 2026
ACON Laboratories, Inc.	4	July 10, 2026
Visby Medical, Inc.	4	May 27, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	160	October 30, 2026
PMA 30-day notice	86	October 27, 2026
PMA real-time process supplement	38	August 27, 2026
De Novo (dual track)	35	October 27, 2026
PMA 180-day supplement	26	August 27, 2026
510(k) special	21	October 22, 2026
PMA 135-day supplement	3	September 18, 2025
PMA original approval	2	May 7, 2026
PMA panel track supplement	2	February 3, 2026
PMA special supplement	2	September 19, 2025
De Novo	2	May 9, 2025

By state or country

State or country	Decisions	Latest
California	100	October 30, 2026
Minnesota	71	October 19, 2026
Illinois	40	September 23, 2026
Maryland	23	October 27, 2026
Indiana	19	October 2, 2026
Ohio	13	September 25, 2025
New York	11	October 17, 2025
Germany	10	October 23, 2026
Maine	8	October 30, 2026
Massachusetts	8	July 23, 2026
Utah	7	October 21, 2026
Missouri	7	October 1, 2026
Georgia	6	October 14, 2026
China	6	April 30, 2026
United Kingdom	5	July 24, 2026
Italy	5	April 17, 2026
New Jersey	5	January 15, 2026
France	4	April 21, 2026
Texas	3	October 21, 2026
Nebraska	3	March 27, 2026
Florida	3	February 5, 2026
North Carolina	2	September 11, 2026
Washington	2	October 12, 2025
Canada	1	June 10, 2026
Delaware	1	June 5, 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.