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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3302 of 3528

510(k) clearances, page 3302 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K803308	Fashion Sunglasses	Grand Imperial, Inc.	HQY	Class I	1981-04-03
K803128	Series 810 Platelet Analyzer	J.T. Baker Chemical Co.	GKL	Class II	1981-04-03
K810627	Model 1301 Biotac (Tm)	Progress Mankind Technology	GEA	Class I	1981-04-02
K810080	Vascular Tie (Vas-Tie)	Sil-Med Corp.	KDC	Class I	1981-04-02
K810804	Progesterone Kit	Cambridge Nuclear Corp.	JLS	Class I	1981-04-01
K810794	A-Gent Urea Nitrogen	Abbott Medical	CDQ	Class II	1981-04-01
K810719	Replica Plater	Dynatech Corp.	JTC	Class I	1981-04-01
K810566	Siemens Model 146-146A External Pulse G	Cynergy	DTE	Class II	1981-04-01
K810471	Stock Antimicrobic Solutions	Cathra International, Inc.	LOP	Class II	1981-04-01
K810385	Cyberlith I Pulse Generator Model 253-04	Intermedics, Inc.	DXY	Class III	1981-04-01
K810383	Intermedics Cyberlith I Biopolar Cardi	Intermedics, Inc.	DXY	Class III	1981-04-01
K810791	Pentax Colonoscope Model Fc-34 Ma	Pentax Precision Instrument Corp.	FDF	Class II	1981-03-31
K810787	Urologic Tube Holder	The Urology Group	OCV	Class II	1981-03-31
K810754	Lutenizing Hormones	Pcl-Ria, Inc.	CEP	Class I	1981-03-31
K810753	Airway Pressure Monitor	ZOLL Medical Corporation	CAP	Class II	1981-03-31
K810745	Double Lumen Subclavin Catheter Sc-400	Vas-Cath of Canada, Ltd.	LFJ	Class II	1981-03-31
K810743	Lecithin-Spingomyelin Stand. & Kits	Supelco, Inc.	JIS	Class II	1981-03-31
K810742	Aqueous Triolein Standards & Kits	Supelco, Inc.	JIS	Class II	1981-03-31
K810741	Luteinizing Hormone	Pcl-Ria, Inc.	CEP	Class I	1981-03-31
K810738	Goode Magnetic Nasal Splint	Xomed, Inc.	EPP	Class I	1981-03-31
K810736	Luminescence Photometer 100 Series	Sai Technology	JJQ	Class I	1981-03-31
K810727	Ast-UV (Plp-Activated) Determination	The Dow Chemical Co.	CIT	Class II	1981-03-31
K810725	Qualitrol #65057	Harleco	JJT	Class I	1981-03-31
K810724	Corning 178 Blood Gas Analyzer	Corning Medical & Scientific	CHL	Class II	1981-03-31
K810718	C-Peptice Reagents	Calbiochem-Behring Corp.	JKD	Class I	1981-03-31
K810717	Coat-a-Count T3 Uptake Kit	Siemens Healthcare Diagnostics Inc.	KHQ	Class II	1981-03-31
K810695	Estriol Radioimmunoassay Test Kit	Serono Laboratories, Inc.	CHP	Class I	1981-03-31
K810680	Enzymatic Triglyceride	Horiba Instruments Incorporated	CDT	Class I	1981-03-31
K810674	Glucose Oxidase	Horiba Instruments Incorporated	CGA	Class II	1981-03-31
K810673	Enzymatic Cholesterol	Horiba Instruments Incorporated	CHH	Class I	1981-03-31
K810669	Pantrak E.k.	Calbiochem-Behring Corp.	CIW	Class II	1981-03-31
K810667	Amerlex Estriol Ria Kit	Amersham Corp.	CGI	Class I	1981-03-31
K810664	Isolator System	E.I. Dupont de Nemours & Co., Inc.	JKA	Class II	1981-03-31
K810662	Leeco Lh-Quant Diagnostic Kit	Leeco Diagnostics, Inc.	CEP	Class I	1981-03-31
K810659	Autodiluter III	Dynatech Corp.	JTC	Class I	1981-03-31
K810658	Rpr Card Test System	Beckman Instruments, Inc.	GMQ	Class II	1981-03-31
K810652	Tubing Connectors	First Industries, Inc.	BYX	Class I	1981-03-31
K810651	Oral Airways	First Industries, Inc.	CAE	Class I	1981-03-31
K810639	Seralyzer System	Miles Laboratories, Inc.	CGA	Class II	1981-03-31
K810630	Silicone Elastomer Coated Latex Foley	G.D. Searle and Co.	KOD	Class II	1981-03-31
K810618	Ampuled Flame Photometer Standards	United Diagnostics, Inc.	JIS	Class II	1981-03-31
K810599	Dade Rh Control Reagent	American Dade	KSF	Class II	1981-03-31
K810577	Power Sonic	Qualitone	ESD	Class I	1981-03-31
K810564	Cefotaxime 30 Mcg. Sensi-Disc.	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1981-03-31
K810546	Cefotaxime 30 Mcg. Sensitivity Discs.	Difco Laboratories, Inc.	JTN	Class II	1981-03-31
K810528	Model Em-Ir	Myo-Tronics Research, Inc.	KZM	Class II	1981-03-31
K810474	Probe Cover	Narco Air-Shields	FLL	Class II	1981-03-31
K810427	Cefotaxime 30Mcg Antimicrobial Suscep.	Pfizer Pharmaceuticals	JTN	Class II	1981-03-31
K810392	Oesophageal Therapy Kit	Keymed, Inc.	KNT	Class II	1981-03-31
K810365	Haemonetics 170 Y Infusion Set	Haemonetics Corporation	FPA	Class II	1981-03-31