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 1902 of 3531

510(k) clearances, page 1902 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970564	Dynamic Wedge	Mitsubishi Electronics America, Inc.	IYE	Class II	1997-05-12
K970556	Surestep Pro Blood Glucose Monitoring System	Lifescan, Inc.	CGA	Class II	1997-05-12
K970536	Medisystems Tranducer Protector	Medisystems Corp.	FIB	Class II	1997-05-12
K970517	Innofluor Topiramate Control Set	Oxis Intl., Inc.	LAS	Class I	1997-05-12
K970510	Innoflour Topiramate Reagent Set	Oxis Intl., Inc.	MSL	Class II	1997-05-12
K970509	Innoflour Calibrator Reagent Set	Oxis Intl., Inc.	DLJ	Class II	1997-05-12
K970094	Model Dx Micro Computer Control	Invacare Respiratory Corp.	ITI	Class II	1997-05-12
K963340	Medlite Nd:yag Laser System: New Dye Accessory Handpiece	Continuum Biomedical, Inc.	GEX	Class II	1997-05-12
K961631	Odont Hex System	Odontit SA	DZE	Class II	1997-05-12
K971389	Eclipse 400 Manually Operated Wheelcair	Pdg Product Design Group Inc	IOR	Class I	1997-05-09
K971327	Unika	Eyewear Partners Co.	HQY	Class I	1997-05-09
K971048	Peri-Strips Dry - Staple Line Reinforcement	Bio-Vascular, Inc.	FTM	Class II	1997-05-09
K970982	T-Rx Retrieval Forceps	Tri-Med Specialties, Inc.	OCZ	Class II	1997-05-09
K970779	Osteonics Tibial Tray Screw Hole Plugs	Osteonics Corp.	LZN	Class II	1997-05-09
K970757	Fotona Skinscan	Medical Laser Solutions	GEX	Class II	1997-05-09
K970748	Taylor Spatial Frame External Fixation System	Smith & Nephew, Inc., Orthopaedic Div.	KTT	Class II	1997-05-09
K970746	See3 (Lotrafilcon a) Soft Contact Lens	Alcon Laboratories	LPL	Class II	1997-05-09
K970725	Opti-Plast Xl 5.5 F Pta Catheter	Vas-Cath, Inc.	LIT	Class II	1997-05-09
K970710	Stat Profile Ultra M Analyzer	Nova Biomedical Corporation	CHL	Class II	1997-05-09
K970587	Ad-Tech Subdural Electrode	AD-Tech Medical Instrument Corp.	GYC	Class II	1997-05-09
K970516	Sullivan Autoset Home Nasal CPAP System	ResMed Corp	BZD	Class II	1997-05-09
K970496	Heartport Maze System: Cryoprobe Set	Heartport, Inc.	OCL	Class II	1997-05-09
K970494	Hannibal Guidewire	Schneider (Europe) GmbH	DQX	Class II	1997-05-09
K970441	K-Klosure 2 Inch Length/4 Inch Length/8 Inch Length/12 Inch Length	Medi-Flex Hospital Products, Inc.	FPX	Class I	1997-05-09
K970426	Valuetrode	Axelgaard Mfg. Co., Ltd.	GXY	Class II	1997-05-09
K965103	Winmax Software Systems	Siemens Healthcare Diagnostics Inc.	JJF	Class I	1997-05-09
K964781	Immage Immunochemistry System Prealbumin (Pab) Reagent	Beckman Instruments, Inc.	DDS	Class I	1997-05-09
K964710	Bledsoe Cold Control	Med Technology, Inc.	ILO	Class II	1997-05-09
K964644	Ad-Tech's Depth Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1997-05-09
K964302	Heartport Thoracic Trocar	Heartport, Inc.	DRC	Class II	1997-05-09
K964239	Combination Oximeter/carbon Dioxide Gas Analyzer	Spegas Industries, Ltd.	CCK	Class II	1997-05-09
K963256	Neuromate Stereotactic System	Integrated Surgical Systems, Inc.	HAW	Class II	1997-05-09
K961805	Tomey Dtl Electrode	Tomey Corporation USA	HLZ	Class II	1997-05-09
K961608	Synthes (u.s.a.) Polypin	Synthes (USA) Products LLC	HTY	Class II	1997-05-09
K954577	Ws Frequency Spectrum Effect Physiatrics Apparatus	C.A.I. Industries Corp.	ILY	Class II	1997-05-09
K971317	National Medical Healthcare Custom Orthopedic Kits and Trays	National Healthcare Mfg. Corp.	KDD	Class I	1997-05-08
K971297	Centre-Drive Drill-Free Screw	KLS-Martin L.P.	HRS	Class II	1997-05-08
K971287	Synchron Systems Drug Calibration 3 Plus	Beckman Instruments, Inc.	DKB	Class II	1997-05-08
K971286	Ez Sure (Excel) Urine Midstream Pregnancy Home Test	Excel Scientific, Inc.	LCX	Class II	1997-05-08
K971196	Endopore Endosseous Dental Implant System	Innova Corp.	DZE	Class II	1997-05-08
K970884	Resolut Regenerative Material	W. L. Gore & Associates, Inc.	LYC	Class II	1997-05-08
K970813	Dims (Digital Imaging and Medical System) Cl1-5110/5111	Denvu, Inc.	LLZ	Class II	1997-05-08
K970717	Vapor-Tech Sled Electrode	Northgate Technologies Inc.	FAS	Class II	1997-05-08
K970692	Unitron Model Sound F/x Cic	Unitron Industries, Inc.	ESD	Class I	1997-05-08
K970600	Dermamend Foam Island Dressing	Dermarx Corp.	KMF	Class I	1997-05-08
K970545	Dash 1000 Patient Monitor	Marquette Medical Systems, Inc.	DSI	Class II	1997-05-08
K970469	Evt Angioscale Angiographic Catheter	Guidant Cardiac and Vascular Surgery	DQO	Class II	1997-05-08
K970457	Dukal Abd Combine Pad	Dukal Corp.	EFQ	Unclassified	1997-05-08
K970455	Dukal Non Adherent Dressing	Dukal Corp.	EFQ	Unclassified	1997-05-08
K965224	Empower Anterior Direct Screws	Smith & Nephew Richards, Inc.	KWP	Class II	1997-05-08