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 2015 of 3531

510(k) clearances, page 2015 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955188	Sas Salmonella H Z6 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955187	Sas Salmonella H Z4, Z23 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955186	Sas Salmonella H Z29 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K954934	Candela Sptl Long Pulse/tunable Pulsed Dye Lase	Candela Corporation	GEX	Class II	1996-02-02
K954294	High Transmission Cellular (Htc) Grids 18X24 Cm & 24X30 Cm Sizes	Thermotrex Corp.	IXJ	Class I	1996-02-02
K954161	Jpi Intensifying Screen	JPI Healthcare Co., Ltd	EAM	Class I	1996-02-02
K953579	Tee Probe	Biosound, Inc.	ITX	Class II	1996-02-02
K953564	Medtronic Overpressure/vacuum Relief Valve	Medtronic Cardiac Surgery, Medtronic, Inc.	DTL	Class II	1996-02-02
K952390	Brainlab Sterotatic Headring	Brainlab Med. Computersysteme GmbH	HAW	Class II	1996-02-02
K951246	Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options	Protocol Systems, Inc.	FLS	Class II	1996-02-02
K945264	Optus Otoscopes	Optus, Inc.	ERA	Class I	1996-02-02
K943224	Varian Multileaf Collimator	Varian Assoc., Inc.	IYE	Class II	1996-02-02
K955836	Valleylab Coated Electrodes	Medtronic, Inc.	GEI	Class II	1996-02-01
K955683	Rns Sterile, Disposable Breast Biopsy/localization Tray	Contour Fabricators of Florida, Inc.	MJG	Class I	1996-02-01
K955404	Otv-S5 Oes Video System	OLYMPUS Corporation of the Americas	GCJ	Class II	1996-02-01
K955364	Seamguard Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	OXD	Class II	1996-02-01
K954848	Hemashield Microvel Velour Knitted Vascular Graft	Meadox Medicals, Div. Boston Scientific Corp.	MAL	Class II	1996-02-01
K954714	Afp Cardiac Pacing System Model 283 (Modification)	Pacesetter, Inc.	DTB	Class III	1996-02-01
K954169	Hanaulux Blue 30 & 80	Heraeus Med GmbH	FSY	Class II	1996-02-01
K953703	Depuy Vision Solution Hip Prosthesis	Depuy, Inc.	LPH	Class II	1996-02-01
K953694	Depuy Vision Aml Hip Prothesis	Depuy, Inc.	LPH	Class II	1996-02-01
K950481	Neonatal Chemistry System, Galactose Test Kit	Isolab, Inc.	JIA	Class I	1996-02-01
K955752	Olympus Uric Acid Reagent	OLYMPUS Corporation of the Americas	CDO	Class I	1996-01-31
K955510	X6000d Silent Sun Light Source	Products for Medicine	FST	Class II	1996-01-31
K955408	Microsurge Thoracoscopic Instruments	Microsurge, Inc.	GCJ	Class II	1996-01-31
K955388	Ace-Dupont Composite Rings	Ace Medical	LXT	Class II	1996-01-31
K955111	Maxi-Torque Plus Angiographic Catheter	Adam Spence Corp.	DQO	Class II	1996-01-31
K955040	At-III Control Plasma Kit	American Bioproducts Co.	GGC	Class II	1996-01-31
K955033	Rim Flare Acetabular Component	Intermedics Orthopedics	LPH	Class II	1996-01-31
K955003	Biofix Biodegradable Self-Reinforced Poly-L-Lactide (Sr-Plla) Mini-Tack	Bioscience, Inc.	MAI	Class II	1996-01-31
K954909	Profix Posterior-Stabilized Knee System	Smith & Nephew Richards, Inc.	JWH	Class II	1996-01-31
K954835	Holgrath Combined Spinal Epidural Needle Set	Holgrath Medical Technologies, Inc.	CAZ	Class II	1996-01-31
K954787	Illuminator	Hospitak, Inc.	CCW	Class I	1996-01-31
K954443	Lactosorb Suture Anchor	Poly-Medics,Inc.	JDR	Class II	1996-01-31
K954207	Gel Mask	Respironics, Inc.	BZD	Class II	1996-01-31
K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	GEX	Class II	1996-01-31
K953925	Fine Grain Cast Cobalt Chromium Hip Stems	Zimmer GmbH	LZO	Class II	1996-01-31
K953609	Prodek	Sutures, Ltd.	GAW	Class II	1996-01-31
K953560	Mitek Threaded Anchor (Fastin)	Mitek Surgical Products, Inc.	MBI	Class II	1996-01-31
K953202	P.f.c. Size 0 Cemented Femoral Component	Johnson & Johnson Professionals, Inc.	JDI	Class II	1996-01-31
K953200	Ultima Size 0 Cemented Femoral Stem	Johnson & Johnson Professionals, Inc.	JDI	Class II	1996-01-31
K952859	Ultima Cemented Long Stem Femoral Component	Johnson & Johnson Professionals, Inc.	JDI	Class II	1996-01-31
K952491	Model 7355	Devilbiss Health Care, Inc.	BZD	Class II	1996-01-31
K945938	Respironics Monarch Mini Mask	Respironics, Inc.	BZD	Class II	1996-01-31
K945215	Mars Digital Blood Pressure Monitor	Mars Metal Co., Ltd.	DXN	Class II	1996-01-31
K955704	Trebay Microdebrider System	Trebay Medical Corp.	EQJ	Class I	1996-01-30
K955697	Abutment Retrieval Kit	Nobelpharma USA, Inc.	DZE	Class II	1996-01-30
K955492	Interpore Imz Cyl Implant & Cyl Hex Implt	Interpore Intl.	DZE	Class II	1996-01-30
K955482	Swift Infant Oxygen Hood-Reusable (Modification)	Advantage Medical Services, Inc.	FOG	Class I	1996-01-30
K955385	Johnson & Johnson Austin Moore Stem	Johnson & Johnson Professionals, Inc.	KWL	Class II	1996-01-30