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 2131 of 3531

510(k) clearances, page 2131 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945817	Sunglasses	Walmart Stores	HQY	Class I	1995-01-05
K945735	Sunlgasses, Sport Sunglasses & Fishing Glasses	Shu Gie Industrial Co., Ltd.	HQY	Class I	1995-01-05
K945683	Vetta Lightweight Cycling Eyewear	Shaw, Pittman, Potts & Trowbridge	HQY	Class I	1995-01-05
K945655	Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test System)	Miles, Inc.	CGX	Class II	1995-01-05
K945293	Top Acom Station	Siemens Medical Solutions USA, Inc.	IZI	Class II	1995-01-05
K945240	Irma Blood Analysis System	Diametrics Medical, Inc.	CHL	Class II	1995-01-05
K945147	Pectacle Frames And/or Sunglasses	Mi MI Progress Co., Ltd.	HQY	Class I	1995-01-05
K944858	Baxter Eptfe Externally Supported Vascular Grafts	Baxter Edwards	DSY	Class II	1995-01-05
K944258	Calcium Reagent	OLYMPUS Corporation of the Americas	CIC	Class II	1995-01-05
K943380	Siemens 10A Faceplate with Cic Instruments	Siemens Hearing Instruments, Inc.	ESD	Class I	1995-01-05
K942837	Dst-Xl	Sopha Medical Systems, Inc.	KPS	Class II	1995-01-05
K941096	Electric Vacum Pump	ZOLL Medical Corporation	BTA	Class II	1995-01-05
K936039	Algo-2 Newborn Hearing Screener	Bio-Logic Systems Corp.	GWJ	Class II	1995-01-05
K934699	Respironics Bageasy Encor Adult Semi-Reusable	Respironics, Inc.	BTM	Class II	1995-01-05
K933870	Viba-Brush	Rovers B.V.	HHT	Class II	1995-01-05
K945732	Fog Free	Tonn Chemical Co., Inc.	OCT	Class II	1995-01-04
K945316	Phenobarbital Calibrators	Diagnostic Reagents, Inc.	DLJ	Class II	1995-01-04
K945201	Coverd Gianturco-Rosch Esophageal Z-Stent	Cook Inc.	ESW	Class II	1995-01-04
K944875	Angiomat 3000, 6000, CT Injector	Lievel-Flarsheim Co.	DXT	Class II	1995-01-04
K943614	A.w.e.l.	Medi-Flex	GCJ	Class II	1995-01-04
K943581	Hydradjust IV Urological Table	Mallinckrodt Group, Inc.	IXR	Class II	1995-01-04
K941429	IV Catheter and Obturator	Becton Dickinson Vascular Access, Inc.	FOS	Class II	1995-01-04
K935964	Ideas Occluder	Ideas for Medicine, Inc.	DXC	Class II	1995-01-04
K935023	Godat Uterine Manipulator Injector	Ideas for Medicine, Inc.	LKF	Class II	1995-01-04
K930052	Siemens Quantum 7E11 Transrectal Transducer	Siemens Quantum, Inc.	ITX	Class II	1995-01-04
K945906	Silicone Punctal Plug	Oasis Medical, Inc.	LZU	Unclassified	1995-01-03
K945604	Ecliptomer	Bisco, Inc.	KLE	Class II	1995-01-03
K941831	Lubricating Jelly	Barre-National, Inc.	HIS	Class II	1995-01-03
K935186	Electrophysiology Systems, Inc. Ep-Easy	Electrophysiology Systems, Inc.	DQK	Class II	1995-01-03
K926139	Cathlink 20 Titanium Port W/att. Polyurethane Cath	Bard Access Systems, Inc.	LJT	Class II	1995-01-03
K945534	Mechanical Wheelchair - Boing	Colours 'N Motion	IOR	Class I	1995-01-02
K945533	Mechanical Wheelchair - Supernova	Colours 'N Motion	IOR	Class I	1995-01-02
K945247	Powderfree Latex Examination Glove	Sri Johani Sdn. Bhd.	LYY	Class I	1995-01-02
K945045	Patient Exaination Gloves	Phoenix Medical Technology, Inc.	LYY	Class I	1995-01-02
K943034	Orex Shoe Covers	Thantex Specialties, Inc.	FXP	Class I	1995-01-02
K942294	Asep Plus Surgical Drapes	Angelica Uniform	KKX	Class II	1995-01-02
K933602	Patient Examination Glove	Kerala Rubber & Reclaims, Ltd.	LYY	Class I	1995-01-02
K945159	Scimed Pursuit Exchange Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1994-12-30
K944986	Emsee Labs Model C	Emsee Lab of Florida	ESD	Class I	1994-12-30
K944985	Emsee Labs Mode M	Emsee Lab of Florida	ESD	Class I	1994-12-30
K944984	Emsee Labs Model S	Emsee Lab of Florida	ESD	Class I	1994-12-30
K944777	Orion Ppm, Pp, Pp-D	Rexton, Inc.	ESD	Class I	1994-12-30
K944555	Endoscope	United States Surgical, A Division of Tyco Healthc	HET	Class II	1994-12-30
K944386	R&d Batteries Part Nos. 5354 and 5150	R & D Batteries, Inc.	FCO	Class I	1994-12-30
K944294	R&d Batteries, Inc. Part Numbers 5162, 5040, 5237, and 5102	R & D Batteries, Inc.	FCO	Class I	1994-12-30
K943800	2D,3d, Tof Mr Angiography	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-12-30
K943675	Enteral Delivery Sets with Hydration Port	Clintec Technologies, Inc.	KNT	Class II	1994-12-30
K943392	Thera-Flow Gradient Sequential Pump	Meds Systems, Inc.	JOW	Class II	1994-12-30
K940191	Electrosurgical Loop Electrode	National Wire & Stamping, Inc.	HGI	Class II	1994-12-30
K940121	Implanters/adjustable/anderson's Markers	Best Industries	IWJ	Class I	1994-12-30