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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2361 of 3531

510(k) clearances, page 2361 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922449	Pa-400	J.F. Jelenko & Co., Inc.	EJS	Class II	1992-08-05
K922448	Benchmark I	J.F. Jelenko & Co., Inc.	EJS	Class II	1992-08-05
K922447	Benchmark III	J.F. Jelenko & Co., Inc.	EJS	Class II	1992-08-05
K922446	Accu-Star	J.F. Jelenko & Co., Inc.	EJS	Class II	1992-08-05
K922322	Alphatec 3.5Mm Znnulated Cortical Lag Screw	Alphatec Spine, Inc.	HWC	Class II	1992-08-05
K922144	Citscope (Model Extensions)	Citation Medical Corp.	HRX	Class II	1992-08-05
K922047	Ige Enzyme Immunoassay Test Kit Cat.no. Kif4064	Medix Biotech, Inc.	DGC	Class II	1992-08-05
K921617	Cylinder of Gas, Can of Gas (Cc12f2)	Bio-Rad	HKX	Class II	1992-08-05
K921348	Oic Model J4 Tmj Cpm	Lm Product Design, Inc.	BXB	Class I	1992-08-05
K920666	Intramedulary Fixation Rod	Acu Med, Inc.	HSB	Class II	1992-08-05
K920525	Biotrack Therapeutic Drug Monitoring Qual. Control	Biotrack, Inc.	DIS	Class II	1992-08-05
K920354	Ophthalmic Sponges	Ultracell Medical Technologies, Inc.	HOZ	Class II	1992-08-05
K920204	Instascan	Advanced Nmr Systems, Inc.	LNH	Class II	1992-08-05
K915698	Fibrinostika Tdp Microelisa System	bioMerieux, Inc.	DAP	Class II	1992-08-05
K914473	Suntiger/eagle 475/Avian-Avian/pst 475 Sunglasses	Biomedical Optics Co. of America, Inc.	HQY	Class I	1992-08-05
K912270	Polycath #Wmc-900	Worldwide Medical Corp.	DQO	Class II	1992-08-05
K923340	Roche Abuscreen Onlinne Calibrators	Roche Diagnostic Systems, Inc.	DKB	Class II	1992-08-04
K923028	Turkel Pneumothorax Kit	Boston Scientific Corporation	GCB	Class I	1992-08-04
K922835	Calcium (Az III) Reagent	King Diagnostics, Inc.	CJY	Class II	1992-08-04
K922090	Force Gsu System W/ Laparoscopic Option	Medtronic, Inc.	GEI	Class II	1992-08-04
K921841	Cynosure Photogenica P Pigmented Lesion Laser	Cynosure, LLC	GEX	Class II	1992-08-04
K921350	Qualtex Tube/cord Organizer	DeRoyal Industries, Inc.	KKX	Class II	1992-08-04
K921120	Flexible Cystoscopy Introducing Catheter	Cook Incorporated	FED	Class II	1992-08-04
K920397	Reflab System Pack Liquid Fructosamine Reagent	Medical Analysis Systems, Inc.	LCP	Class II	1992-08-04
K915054	Statim Cassett Autoclave, Modification	Scican Ltd.	FLE	Class II	1992-08-04
K923618	PEEP Valve	International Respiratory Systems, Inc.	BYE	Class II	1992-08-03
K923217	Danniflex Cpm 2000	Buckman Co., Inc.	BXB	Class I	1992-08-03
K923216	Danninflex Cpm 800	Buckman Co., Inc.	BXB	Class I	1992-08-03
K923050	Nd:yag Laser-12	Laser Endo Technic	GEX	Class II	1992-08-03
K922967	Fortress 1700Fs Rear Wheel Drive Scooter	Fortress Scientific, Ltd.	INI	Class II	1992-08-03
K922966	Fortress 1704Fs Four Wheel Scooter	Fortress Scientific, Ltd.	INI	Class II	1992-08-03
K922615	Coltene A.r.t. Bond	Coltene /Whaledent AG	KLE	Class II	1992-08-03
K922114	Endoscopic Retrieval Basket	Intramed Laboratories, Inc.	FFL	Class II	1992-08-03
K922082	Laparoscopic Introducer	Endomedix	GCJ	Class II	1992-08-03
K921994	Bard Pca II Pump with Program Cartridges	C.R. Bard Inc	MEA	Class II	1992-08-03
K921896	Tilting Mag	Continental X-Ray Corp.	IZH	Class II	1992-08-03
K921855	Biotrol Bicarbonate Standards	Biotrol, USA, Inc.	JIS	Class II	1992-08-03
K921668	Staodyn Tuwave	Staodyne, Inc.	IPF	Class II	1992-08-03
K921574	White Ash - Fraxinus Americana (T15) Allergen Disc	Hycor Biomedical	DHB	Class II	1992-08-03
K921318	Adapting Sleeve Kit Model 4023	Siemens-Pacesetter, Inc.	DTD	Class II	1992-08-03
K921265	Diastat Anti-Cardiolipin Kit	Shield Diagnostics, Ltd.	MID	Class II	1992-08-03
K920954	Air Star	Infrasonics Corp.	BTI	Class II	1992-08-03
K920698	Femoral and All Poly Tibial Tray Components	Orthomet, Inc.	JWH	Class II	1992-08-03
K920426	Psk Femoral and Tibial Insert Component	Orthomet, Inc.	JWH	Class II	1992-08-03
K920360	Timox Oxygen Timer	Medical Fittings, Inc.	BXP	Class I	1992-08-03
K915416	Fymco Flyer	Motion Dynamics	INI	Class II	1992-08-03
K913102	Peters Cardionyl(tm) Suture	Promedica Products, Inc.	GAR	Class II	1992-08-03
K923268	Affirm Processor	Microprobe Corp.	JQW	Class I	1992-07-30
K923226	Eurion Lotos Pp Hearing Aid	Eurion Hearing Instruments	ESD	Class I	1992-07-30
K922973	Restcue Cc	Support Systems Intl.	IOQ	Class II	1992-07-30