510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,502

176,299 records, page 3410 of 3526

510(k) clearances, page 3410 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790645	Endotome	Berkeley Bio-Engineering	HSZ	Class I	1979-04-23
K790639	Gonad Shield	The Mochlett Laboratories, Inc.	KPY	Class I	1979-04-23
K790629	Kodak Gray Tone Imaging Film	Eastman Kodak Company	IWZ	Class I	1979-04-23
K790628	Lombard-Dowell Necmycin Egg Yolk Agar	Anaerobe Systems	JSI	Class I	1979-04-23
K790626	Lombard-Dowell Glucose Agar	Anaerobe Systems	JSF	Class I	1979-04-23
K790624	Lombard-Dowell Broth Medium W/lactate	Anaerobe Systems	JSI	Class I	1979-04-23
K790623	Lombard-Dowell Milk Agar	Anaerobe Systems	JSH	Class I	1979-04-23
K790622	Chopped Meat Agar	Anaerobe Systems	JSG	Class I	1979-04-23
K790621	Chopped Meat Glucose Medium	Anaerobe Systems	JSG	Class I	1979-04-23
K790620	Lombard Dowell Broth Mediumw/th Reonine	Anaerobe Systems	JSC	Class I	1979-04-23
K790619	Lombard-Dowell Broth Medium	Anaerobe Systems	JSC	Class I	1979-04-23
K790618	Lombard-Dowell Starch Agar	Anaerobe Systems	JSH	Class I	1979-04-23
K790617	Carbohydrate Fermentation Media	Anaerobe Systems	JSE	Class I	1979-04-23
K790616	Enriched Thioglycollate Medium	Anaerobe Systems	JSC	Class I	1979-04-23
K790615	Chopped Meat Medium	Anerobe Systems	JSC	Class I	1979-04-23
K790614	Lombard-Dowell Medium with Glucose	Anerobe Systems	JSC	Class I	1979-04-23
K790613	Chopped Meat Glocose Starch Medium	Anerobe Systems	JSC	Class I	1979-04-23
K790610	Sigmoidoscope Tipless	Welch Allyn Inc	FAM	Class II	1979-04-23
K790606	Catheters, Greenline Suction	Snyder Laboratories, Inc.	BSY	Class I	1979-04-23
K790583	Quik Column Methodology	Helena Laboratories, Corp.	LCP	Class II	1979-04-23
K790577	Hemorrhoidal Ligator	J. Sklar Mfg. Co., Inc.	HCF	Class I	1979-04-23
K790571	Quik-Stain	Dade, Baxter Travenol Diagnostics, Inc.	IAF	Class I	1979-04-23
K790540	Ria Test Kit, Centria Digoxin	Ventrex Laboratories, Inc.	DPB	Class II	1979-04-23
K790490	Neia-Ferritin Enzymeimmunassay Kit	New England Immunology Assoc.	DBF	Class II	1979-04-23
K790489	Microview	Philips North America LLC	IYO	Class II	1979-04-23
K790486	Flozyme* Uric Acid Reagent	Worthington Diagnostic Systems	KNK	Class I	1979-04-23
K790447	Ventre/sep Ferritin Ria	Ventrex Laboratories, Inc.	DBF	Class II	1979-04-23
K790430	Medica II-F-Asma Test Kit	Medica Corp.	DBE	Class II	1979-04-23
K790420	Suction Connecting Tubing	Snyder Laboratories, Inc.	BYY	Class II	1979-04-23
K790419	Yankauer & Poodle Suction Instruments	Snyder Laboratories, Inc.	BYY	Class II	1979-04-23
K790369	Emb/mueller-Hinton Agar	Biomedia, Inc.	JTZ	Class II	1979-04-23
K790362	I Bradykinin & Anti-Bradykinin Antiserum	Cambridge Nuclear Corp.			1979-04-23
K790280	Autoantibody Reagents, Aft System II	Calbiochem-Behring Corp.	DHN	Class II	1979-04-23
K790193	Mizzy Syrijet Mark IV	Mizzy, Inc.	EGM	Class II	1979-04-23
K782013	Gono-Cell	Abbott Medical	JSX	Class I	1979-04-23
K790422	Multiskan (78-503-00)	Flow Laboratories, Inc.	JJQ	Class I	1979-04-20
K790417	T3 Uptake Kit	E. R. Squibb & Sons, Inc.	KHQ	Class II	1979-04-20
K790381	Arteriovenous Sets	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1979-04-20
K790353	Acute Renal Dialysis Tray	Argon Medical Corp.	FKG	Class I	1979-04-20
K790162	Oxygen Mask, Concentration Aerosol Mask	Airlife, Inc.	KGB	Class I	1979-04-20
K790161	Oxygen Mask W/reservoir Bag	Airlife, Inc.	KGB	Class I	1979-04-20
K790156	Trach T W/drainage Bag	Airlife, Inc.	BZA	Class I	1979-04-20
K790733	Ventimeter Ventilator	Narco Air-Shields	CBK	Class II	1979-04-19
K790732	Ventimeter Controller	Narco Air-Shields	CBK	Class II	1979-04-19
K790675	5300 Percussor	Hudson Oxygen Therapy Sales Co.	BYI	Class II	1979-04-18
K790635	Q220f Carditomy Reservoir/modified	Bentley Laboratories, Inc.	DTN	Class II	1979-04-18
K790520	Aircare Oxygen Generator	Medical Services of America, Inc.	CAW	Class II	1979-04-18
K790344	Bipolar Pernenous Ventricular Lead	Cordis US Corp.	DTB	Class III	1979-04-17
K790040	P.a.p. Test Kit, Ria-Zyme	Mallinckrodt Critical Care	JFH	Class II	1979-04-17
K781493	EEG Gel	Graphic Controls Corp.	GYB	Class II	1979-04-17