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 2026-10-15, 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 3224 of 3528

510(k) clearances, page 3224 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821295	Olsen Hegar Needle Holders	Conphar, Inc.	GDF	Class I	1982-06-03
K821289	Mayo-Hegar Needle Holder	Conphar, Inc.	GDF	Class I	1982-06-03
K821127	Key Drill	Key Medical, Inc.	GFG	Class I	1982-06-03
K820782	Theratronic Stimulator	Theratronics, Inc.	IPF	Class II	1982-06-03
K820570	Seamed, #540 - Siemens, #146F Telectro	Seamed Corp.	DTE	Class II	1982-06-03
K820218	Pre-Sterilization of Vitallium Alloy	Howmedica Corp.			1982-06-03
K827507	Endoscopic Accessory u/s/ Cleaning Machine	Keymed House			1982-06-02
K821549	Pacemaker 445 Adapter	Pacesetter Systems	DTD	Class II	1982-06-02
K821548	Pacemaker Connector Plug	Pacesetter Systems	DTD	Class II	1982-06-02
K821547	Pacemaker Unipolar Adapter	Pacesetter Systems	DTD	Class II	1982-06-02
K821520	Model 379 Flow/divider	Marathon	CAW	Class II	1982-06-02
K821490	Silkafix Adhesive Plaster	Selomas, Inc.	KGX	Class I	1982-06-02
K821482	Sterile Hd Pan Set	Hospital Disposables, Inc.	FRG	Class II	1982-06-02
K821471	Ultrazyme Plus Alp #64962,65029&65030	EMD Millipore Corporation	CJE	Class II	1982-06-02
K821470	Ultrachem E-Glu #64976 & 65040	EMD Millipore Corporation	CFR	Class II	1982-06-02
K821469	Ultrachem Gluc-Dh, #65048	EMD Millipore Corporation	LFR	Class II	1982-06-02
K821468	Ultrazyme Plus-Gt, #64959 & 65032	EMD Millipore Corporation	JPZ	Class I	1982-06-02
K821465	Ultrachem Uric Acid Aidh, #65047	EMD Millipore Corporation	CDO	Class I	1982-06-02
K821464	Cardiozyme Plus Ck-Mb, #65045	EMD Millipore Corporation	CGS	Class II	1982-06-02
K821463	Ultrachem Gluc-Dh, #65048	EMD Millipore Corporation	LFR	Class II	1982-06-02
K821461	Ultrachem E-Glu, #64976 & 65040	EMD Millipore Corporation	CFR	Class II	1982-06-02
K821443	Formical	Lerner Laboratories, Inc.	KDX	Class I	1982-06-02
K821433	Beckman Liquid-Stat Ast-UV Liquid	Beckman Instruments, Inc.	CIT	Class II	1982-06-02
K821387	Preg/tex Pregnancy Test	Texas Immunology, Inc.	JHJ	Class II	1982-06-02
K821380	Emit Tox Acetaminophen Control	Syva Co.	LAS	Class I	1982-06-02
K821372	Deseret Intracath Intravenous Catheter	Warner-Lambert Co.	FOZ	Class II	1982-06-02
K821371	Deseret Subclavian Jugular Catheter Set	Warner-Lambert Co.	FOZ	Class II	1982-06-02
K821360	Glyco-Gel Test Kit	Pierce Chemical Co.	LCP	Class II	1982-06-02
K821333	Atrial J Temporary Pacing Electrodess	Medics Instrument Corp.	LDF	Class II	1982-06-02
K821320	Hematoxylin Stain	Sigma Chemical Co.	HYJ	Class I	1982-06-02
K821318	Retic Set	R & D Systems, Inc.	KJN	Class I	1982-06-02
K821300	#2010 Camphylobacter Agar	Biomedia, Inc.	JSI	Class I	1982-06-02
K821216	Interpulse Membrane Oxygenator	Extracorporeal Medical Specialities, Inc.	DTZ	Class II	1982-06-02
K821131	Radioimmunoassay Parathyroid Hormone Mid	Endocrine-Metabolic Center	CEW	Class II	1982-06-02
K820542	Surgikos Incise Drape	Surgikos, Inc.	KKX	Class II	1982-06-02
K820470	Uniflex	Howmedica Corp.	NAB	Class I	1982-06-02
K821561	Versachem Analyzer	EMD Millipore Corporation	JJQ	Class I	1982-06-01
K821493	Littman Oxgal Agar	Granite Diagnostics, Inc.	JSJ	Class I	1982-06-01
K821467	Ultrazyme Plus Got, #64953,65033&65034	EMD Millipore Corporation	CIT	Class II	1982-06-01
K821466	Ultrazyme Plus Ldh, #64950,65038&65039	EMD Millipore Corporation	CFJ	Class II	1982-06-01
K821462	Ultrachem T-Bili, #64971	EMD Millipore Corporation	CIG	Class II	1982-06-01
K821460	Ultrazyme Plus Ck-I, #64978,65027&65028	EMD Millipore Corporation	CGS	Class II	1982-06-01
K821457	Hemacount Wrights Stain Pack II #55952	Accra Laboratories, Inc.	IAF	Class I	1982-06-01
K821441	Enzymatic Cholesteral Oxidase #650550	EMD Millipore Corporation	CHH	Class I	1982-06-01
K821439	Mr 600 Microplate Reader	Dynatech Corp.	JJQ	Class I	1982-06-01
K821431	Xld Agar	Interstate Media	JSI	Class I	1982-06-01
K821430	Mueller Hinton Medium	Interstate Media	JTZ	Class II	1982-06-01
K821429	Mueller Hinton Med. W/5% Sheep Blood	Interstate Media	JTZ	Class II	1982-06-01
K821428	Mueller Hinton Chocolate Med. Enriched	Interstate Media	JTZ	Class II	1982-06-01
K821427	Mannitol Salt Agar	Interstate Media	JSI	Class I	1982-06-01