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 2146 of 3531

510(k) clearances, page 2146 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944889	Allround 4	J.F. Jelenko & Co., Inc.	EJT	Class II	1994-11-17
K944778	Latex Examination Gloves	Pt. Haloni Jane	OPE		1994-11-17
K944515	Serum Protein Controls	Pyramid Biological Corp.	JJX	Class I	1994-11-17
K944185	Isoscan	Isolab, Inc.	JQT	Class I	1994-11-17
K944054	Powder Free Surgeon's Glove	Arent Fox	KGD	Class II	1994-11-17
K944022	Lenschek	Leica, Inc.	HLM	Class I	1994-11-17
K943712	Verdict Opiates	Editek, Inc.	DJG	Class II	1994-11-17
K943710	Verdict Cocaine	Editek, Inc.	DIO	Class II	1994-11-17
K943666	Envision Arthroscopy Visualization System	Envision Surgical System, Inc.	HRX	Class II	1994-11-17
K943642	Herculite Xr & Xrv	Sybron Dental Specialties, Inc.	EBF	Class II	1994-11-17
K943550	Gentamicin Fpia Reagent Set and Calibrators	Sigma Diagnostics, Inc.	LCQ	Class II	1994-11-17
K943508	Insufflator Tubing with Filter	Stryker Corp.	HET	Class II	1994-11-17
K943129	Econostand	Sf Research Corp.	IPL	Class II	1994-11-17
K942710	Disposable Bipolar Coagulating Forceps	Boston Surgical Products, Inc.	GEI	Class II	1994-11-17
K942427	Envision Arthroscope, Cannula,trocar, Obturator, and Probe	Envision Surgical System, Inc.	HRX	Class II	1994-11-17
K942080	Sensatec Endoscopic Instruments	Linvatec Corporation	GEI	Class II	1994-11-17
K941575	Smooth Fit	Hi Tec Implants, Ltd.	DZE	Class II	1994-11-17
K940886	Annelid	KCI USA, Inc.	JCX	Class II	1994-11-17
K936191	Prospect Cryptosporidium Rapid Assay	Alexon Biomedical, Inc.	MHJ	Class II	1994-11-17
K932088	Autopak Sterilization Pouch	Ongard Meddevice Packaging, Inc.	KCT	Class II	1994-11-17
K932086	Autopak Instrument Tray Sterilization Pouch	Ongard Meddevice Packaging, Inc.	KCT	Class II	1994-11-17
K931500	The Permaridge Matrix Chin	Applied Biomaterial Technologies	FWP	Class II	1994-11-17
K945380	Karl Storz Monopolar High Frequency Cords	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1994-11-16
K944241	Magnatone Model M Prewired Faceplate Hearing Aid	Magnatone Hearing Aid Corp.	ESD	Class I	1994-11-16
K944236	Needleless Urine Sampling Port	Kendall Healthcare Products Co. Div.Of Tyco Health	KNX	Class II	1994-11-16
K944030	Desentech Plume-Evac Smoke Evacuation System	Desentech, Inc.	GEI	Class II	1994-11-16
K941226	Airwatch Monitor	Enact Health Management Systems	BZH	Class II	1994-11-16
K940276	Filter, Diffuser	Anspach Mfg., Inc.	HSZ	Class I	1994-11-16
K935246	Arbo H49p, H59p Disposable Monitoring Electrodes	Arbo Medical, Inc.	DRX	Class II	1994-11-16
K945035	Ocl Contour	M-Pact Worldwide, LLC	DXQ	Class II	1994-11-15
K944644	Sunglasses and Spectacle Frames	Hung Wai Metal Manufactory	HQY	Class I	1994-11-15
K944639	Documentr Ammonia/ethanolcalibrator	Casco Standards	JIX	Class II	1994-11-15
K944526	Optical Frames and Sunglasses	Aprilia Eyewear S.p.A.	HQY	Class I	1994-11-15
K944462	Dma Iron Procedure	Data Medical Associates, Inc.	JIY	Class I	1994-11-15
K944435	Dosposable Enoscopic Hernia Surgical Stapler	DeRoyal Industries, Inc.	OCW	Class II	1994-11-15
K944428	Lite-Blade	Eare Consulting Service	CCW	Class I	1994-11-15
K944338	Document R Ammonia / Ethanol Calibration Verification Rest Set	Casco Standards	JJX	Class I	1994-11-15
K944292	Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations Resuable Surgical Stapler Handle	Surgical Innovations Ltd	OCW	Class II	1994-11-15
K944245	Dynabite Laparoscopic Forceps	Portlyn Corp.	HET	Class II	1994-11-15
K944097	Compass Software Module	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-11-15
K944059	Procheq 1 & 2	Prisma Systems	JJY	Class I	1994-11-15
K943954	Aspen Surgical Systems Insufflation Tubing Set with Filter	Conmedcorp	HIF	Class II	1994-11-15
K943739	Softouch Diagnostic Intravascular Catheter	Mallinckrodt Medical	DQO	Class II	1994-11-15
K943500	Emit 2000 Digoxin Assay	Syva Co.	KXT	Class II	1994-11-15
K942497	Angiotensin Converting Enzyme Rea	American Laboratory Products Company	KQN	Class II	1994-11-15
K942331	Danavox Model Cic	GN Danavox, Inc.	ESD	Class I	1994-11-15
K940664	Paper Film	Astro Office Products, Inc.	LLZ	Class II	1994-11-15
K931899	Davol Ats	Davol, Inc.	CAC	Class II	1994-11-15
K926517	Elmed Lbc 50-P	Elmed, Inc.	HIN	Class II	1994-11-15
K945160	Paracentesis Needles/cannulas	Tri-Med Specialties, Inc.	LRO	Class II	1994-11-14