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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3024 of 3529

510(k) clearances, page 3024 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844308	Pit and Fissure Seaants	Dentsply Intl.	EBC	Class II	1985-01-09
K844123	Rx Cby	Jeneric Ind.	EJH	Class II	1985-01-09
K844122	Rx Cbg	Jeneric Ind.	EJH	Class II	1985-01-09
K844056	Thermocouple Sensors, Access. for Electronic Therm	Sensortek, Inc.	FLL	Class II	1985-01-09
K843891	Dopscan Plus Ds1060	Carolina Medical Electronics	IYO	Class II	1985-01-09
K843866	Hemodialysate Solutions	Bicarbolyte Corp.	KPO	Class II	1985-01-09
K843461	Bioglass Ossicular Reconstruction Prosth	American Biomaterials Corp.	ETA	Class II	1985-01-09
K843017	Absorbent Endodontic Point	United Dental Mfg., Inc.	EKN	Class I	1985-01-09
K842757	Ultrascan Digital B	CooperVision, Inc.	IYO	Class II	1985-01-09
K844806	Modify Electrolyte Analyzer Model Sera-210	Horiba Instruments Incorporated	CEM	Class II	1985-01-08
K844773	Eff-Effner Bulbs	Mecron Medical Products, Inc.	FFS	Class II	1985-01-08
K844760	Urol-Qual	Dimension Diagnostics	JJY	Class I	1985-01-08
K844755	Focus Urea Nitrogen	Abbott Medical	CDQ	Class II	1985-01-08
K844721	Innofluor Primidone	Innotron Diagnostics	LKT	Class I	1985-01-08
K844709	Critic-Ars	Dimension Diagnostics	JIX	Class II	1985-01-08
K844685	Coloplast Uro 2002 Urostomy System	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1985-01-08
K844684	Coloplast Uro 2002 Night Drainage System	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1985-01-08
K844638	Electrocaine Model Sr-IV	Electrocaine Medical System	GZJ	Class II	1985-01-08
K844561	Bard Ureteroscopic Cytology Brush	C.R. Bard Inc	FDX	Class II	1985-01-08
K844463	Dermidress	Kells Medical, Inc.	KGX	Class I	1985-01-08
K844399	Respiralex Latex Agglutination Test	Orion Diagnostica, Inc.	GTZ	Class I	1985-01-08
K844343	Top Single Use U.t.w. a-V Fistula Needle Y Type	Top Surgical Manufacturers Co.	FIE	Class II	1985-01-08
K844278	Data-Chem Magnesium	Data Medical Associates, Inc.	JGJ	Class I	1985-01-08
K844251	Alt/gpt Reagent Set	Sterling Biochemical, Inc.	CKA	Class I	1985-01-08
K844125	Lyphochek Pregnancy Control Serum Human	Bio-Rad	JJY	Class I	1985-01-08
K843956	Scimed II Membrane Oxygenator System	Scimed Life Systems, Inc.	DTZ	Class II	1985-01-08
K843707	Medtronic 6957J	Medtronic, Inc.	DTB	Class III	1985-01-08
K843703	Permathane 865 & 867 Unipolar Polyureth	Pacesetter Systems	DTD	Class II	1985-01-08
K843382	Urocystin	Mission Pharmacal Company	JLC	Class I	1985-01-08
K842813	Heparin Coated Arterial Blood Filters	American Bentley	DTM	Class II	1985-01-08
K840366	Cell-Matics Herpes Simplex Virus Detect	Difco Laboratories, Inc.	KIR	Class I	1985-01-08
K833561	Light Reflection Rheography	Instru-Med, Inc.	JOM	Class II	1985-01-08
K844798	Eppendorf Diluter	Medical Technomics, Ltd.	JQW	Class I	1985-01-07
K844745	K-Tube	Midwest Metabolic Support Group	KNT	Class II	1985-01-07
K844710	Eurochima Serum Protein Electrophoresis Method	Logos Scientific, Inc.	JJN	Class I	1985-01-07
K844655	Peridochrom Cholesterol High Performance	Boehringer Mannheim Corp.	CHH	Class I	1985-01-07
K844648	Model 363C Hearing Aid	Telex Communications, Inc.	ESD	Class I	1985-01-07
K844621	Behind the Ear Hearing Aid Bernafon T-88P	Bernafon LLC	ESD	Class I	1985-01-07
K844541	Tryptic Soy Broth	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844540	Cystine Tryptic Agar W/fructose	bioMerieux, Inc.	JSF	Class I	1985-01-07
K844539	Phenol Red Broth W/carbohydrates	bioMerieux, Inc.	JSF	Class I	1985-01-07
K844538	Cooked Meat Medium	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844537	Fluid Thioglycollate Medium W/indicator	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844536	Thioglycollate W/o Indicator	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844534	Campylobacter Cva Agar	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844533	Trichomonas Broth	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844532	Simmons Citrate Agar	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844531	Triple Sugar Iron	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844530	Brain Heart Infusion W/6.5% Sodium Chloride	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844529	Brain Heart Infusion Broth	bioMerieux, Inc.	JSG	Class I	1985-01-07