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 2026-10-21, 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 3001 of 3529

510(k) clearances, page 3001 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850277	Viggo i.v. Accessories-Viggo Extension Tubes Etc.	Viggo Products	FPA	Class II	1985-04-12
K850276	Viggo Neoflon Infusion Cannula	Viggo Products	FOZ	Class II	1985-04-12
K844629	Mast Luminescent Allergy System	Mast Immunosystems	DHB	Class II	1985-04-12
K843694	Mast Allergy System	Mast Immunosystems	DHB	Class II	1985-04-12
K843049	Curing Light	Penn-Med Technology, Inc.			1985-04-12
K851296	Implantable Electrode Lead 030-269 Using Polyureth	Telectronics, Inc.	DTB	Class III	1985-04-11
K850460	Viggo Secalon T Catheter	Viggo Products	FOZ	Class II	1985-04-11
K850280	Viggo Connecta 3-Way Infusion Stopcock	Viggo Products	FMG	Class II	1985-04-11
K850259	Electroencephalograph EEG	Nicolet Biomedical Instruments	GWQ	Class II	1985-04-11
K850108	EMG Surface, Digital Ring, Bar, Grounding, EEG	Nicolet Biomedical Instruments	GXY	Class II	1985-04-11
K850107	Concentric Needle Electrodes-Various Sizes W/conne	Nicolet Biomedical Instruments	GXZ	Class II	1985-04-11
K844392	Cardiostat 1 ECG Recorder	Siemens Elema AB	DPS	Class II	1985-04-11
K844187	Siemens Sirecust 404N Neonatal Monitor	Siemens Medical Solutions USA, Inc.	DRT	Class II	1985-04-11
K843598	Brain Function Mapping Option for Pathf	Nicolet Biomedical Instruments	GWK	Class II	1985-04-11
K843594	Airvit Model 8500	Lasermed Corp.	HQE	Class II	1985-04-11
K851297	Implantable Electrode Lead, 030-270 Using Polyuret	Telectronics, Inc.	DTB	Class III	1985-04-10
K851295	Implantable Electrode Lead 030-271 Using Polyureth	Telectronics, Inc.	DTB	Class III	1985-04-10
K851294	Implantable Electrode Lead 030-272 Using Polyureth	Telectronics, Inc.	DTB	Class III	1985-04-10
K851104	Amerlex-M Luteinizing Hormone Radioimmuno-Kit	Amersham Corp.	CEP	Class I	1985-04-10
K851092	Portable Defibrillator/monitor Ed 425	Honeywell, Inc.	LDD	Class II	1985-04-10
K851079	Beckman Triglycerides Control Levels 1/2 &3	Beckman Instruments, Inc.	JJX	Class I	1985-04-10
K851011	Hofmann G-S60 Single Phase X-Ray Generator	Hofmann X-Ray of America, Inc.	IZO	Class I	1985-04-10
K850958	Blood Gas Sampler Kit	Churchill Corp.	FMF	Class II	1985-04-10
K850948	Tilting Table Radiographic A9006 Tomojupiter	D&R X-Ray Products, Inc.	IXR	Class II	1985-04-10
K850913	Glas Ionomer Cement	Shofu Dental Corp.	EMA	Class II	1985-04-10
K850897	Fukuda Denshi Ds-1020A & Ds-1040A Dynascopy Series	Fukuda Denshi USA, Inc.	DSI	Class II	1985-04-10
K850823	Srx 200 Diagnostic X-Ray, High Voltage Generator	Philips North America LLC	IZO	Class I	1985-04-10
K850820	Percutaneous Catheter Introducer W/cath-Seal & Sid	Universal Medical Instrument Corp.	DYB	Class II	1985-04-10
K850816	Lead Plastic Viewing Panels	Victoreen, Inc.	EAK	Class I	1985-04-10
K850814	Modular X-Ray Barriers	Victoreen, Inc.	EAK	Class I	1985-04-10
K850813	Mobile Lead Plastic X-Ray Barriers	Victoreen, Inc.	IWX	Class I	1985-04-10
K850775	Dental Massaging Picks	L.A.K. Ent., Inc.	JET	Class I	1985-04-10
K850760	Mills Operative Peripheral Angioplasty Catheter	Scimed Life Systems, Inc.	LIT	Class II	1985-04-10
K850706	F-Series Implant	Omni Intl., Inc.	DZE	Class II	1985-04-10
K850652	Pacesetter Systems, Endocardial Firm Lead	Pacesetter Systems	DTD	Class II	1985-04-10
K850622	Oscor Medical Model Tme 64S Bipolar Temp/heart Wir	Oscor Medical Corp.	LDF	Class II	1985-04-10
K850575	Dade Alcohol & Ammonia Controls Level I-Low & II H	American Dade	JJY	Class I	1985-04-10
K850463	Basicam Counter Balance Camera	Siemens Gammasonics, Inc.	IYX	Class I	1985-04-10
K850353	Coronary Infusion Catheter W/sideholes	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1985-04-10
K850216	Cardiac Sector Probe 5.0 Mhz	Siemens Medical Solutions USA, Inc.	JOP	Class II	1985-04-10
K850145	Cardiac Sector Probe 3.5. Mhz	Siemens Medical Solutions USA, Inc.	JOP	Class II	1985-04-10
K850139	Cobe Cop Filter Cardiopulmonary Prebypass Filter	Rapid Diagnostic Laboratories, Inc.	KRJ	Class II	1985-04-10
K850075	Scimed Percutaneous Transluminal Angioplasty Dilat	Scimed Life Systems, Inc.	LIT	Class II	1985-04-10
K850065	Elecath Torkfloat Pacing Probe	Electro-Catheter Corp.	DTB	Class III	1985-04-10
K845009	Rabbit-Personal Computer for Women	Sanimor, Inc.	LHD	Unclassified	1985-04-10
K844791	System Sirecust 400 Siemens Sirecust 456-1A	Analogic Corp.	DSI	Class II	1985-04-10
K844393	Gl Ultrasound Sector 170	Gl Ultrasound, Ltd.	IYO	Class II	1985-04-10
K844248	Ir-192 Implant	Rads S.L., Inc.	IWA	Class II	1985-04-10
K843058	Q-Dop	Quinton, Inc.	JOP	Class II	1985-04-10
K842539	Diagnostic Ultrasound 105 & 110	Diagnostic Ultrasound Corp.	JOP	Class II	1985-04-10