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 2108 of 3531

510(k) clearances, page 2108 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931746	Latex (K82)	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1995-03-21
K930884	Medical Procedure Tray, Modification	Enpak Medical Corp.	LDQ		1995-03-21
K923780	Dentool	Dentool, Inc.	EFB	Class I	1995-03-21
K951138	Models Phoenix and Concept 45 Manual Mechanical Wheelchairs	Invacare GmbH	IOR	Class I	1995-03-20
K951037	Akisu Folding Wheelchair, Models Aw-900, 910, 920, 930, 950 and Aw-820, 830	Akisu Machinery	IOR	Class I	1995-03-20
K950589	Clp High Level High Density Lipo Protein Cholesterol Control-Hl	Creative Laboratory Products, Inc.	JJX	Class I	1995-03-20
K950326	Kenlor Human Spinal Fluid Control	Kenlor Industries, Inc.	JJY	Class I	1995-03-20
K950183	Urine Phencyclidine Screen Flex(tm) Reagent Cartridge	E.I. Dupont de Nemours & Co., Inc.	LCM	Unclassified	1995-03-20
K946026	Howmedica(r) 28Mm Zirconia Femoral Heads	Howmedica Corp.	LZO	Class II	1995-03-20
K946019	Surgicla Instrument Kit	Medical Action Industries, Inc. 306	FRG	Class II	1995-03-20
K945425	Mcintosh, Miller, Foregger Baby	Rudolf Riester GmbH & Co. KG	CCW	Class I	1995-03-20
K945331	Auraflex Hcg	bioMerieux, Inc.	DHA	Class II	1995-03-20
K945228	125Mm Handpiece	PLC Medical Systems, Inc.	GEX	Class II	1995-03-20
K943548	Bioabsorbable Interference Screw	Acufex Microsurgical, Inc.	JDR	Class II	1995-03-20
K942735	Carbon Dioxide (C02)	Teco Diagnostics	KHS	Class II	1995-03-20
K942230	Oxycon-Alpha	Mijnhardt B.V.	BTY	Class II	1995-03-20
K941994	Benzodiazepines and Tricyclic Antidepressants by Hplc	Bio-Rad	LFI	Class II	1995-03-20
K941990	Benozodiazepines and Tricylic Antidepressants by Hplc	Bio-Rad	LFI	Class II	1995-03-20
K950729	Olympus Pr-23Q Disposable Cannula (Ball Tip)	OLYMPUS Corporation of the Americas	ODD	Class II	1995-03-17
K950358	Konica Srx-201 Automatic X-Ra Film Processor	Storch Amini & Munves PC	IXW	Class II	1995-03-17
K946313	Tibial Routers, Femoral Routers and Tube Graft Sizer	Smith and Nephew Donjoy, Inc.	HRX	Class II	1995-03-17
K946190	Drug Dispensing Spike	Gelman Sciences, Inc.	FMF	Class II	1995-03-17
K946185	3301T Oxitemp	Bci Intl., Inc.	DQA	Class II	1995-03-17
K946180	Scimed(r) Entre Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-03-17
K945691	Osteonics(r) Threaded Ha Acetabular Shells	Osteonics Corp.	MEH	Class II	1995-03-17
K945433	Etest/ceftriaxone/haemophilus/pneumococcus	Ab Biodisk	JWY	Class II	1995-03-17
K945087	Ortholoc Advantim Porous Coated Tibial Base	Wrightmedicaltechnologyinc	JWH	Class II	1995-03-17
K944580	Flexsys Mobilemate Equipment Stand	Hill-Rom Inc.	FOX	Class I	1995-03-17
K944571	Pulse Guard 3Fr Electrode	Northgate Technologies Inc.	FFK	Class II	1995-03-17
K944310	Pegasus Biwave Plus System	Pegasus Airwave, Inc.	FNM	Class II	1995-03-17
K943389	Sidestream Pump Plug-in Module of Component Monitoring System	Hewlett-Packard Co.	CCK	Class II	1995-03-17
K942941	Conquest Male Continence System	Convatec, A Bristol-Myers Squibb Co.	EXJ	Class I	1995-03-17
K942698	Vacstar	Air Techniques, Inc.	EIA	Class I	1995-03-17
K942381	Low Pressure Injection Tubing, Coiled Line, Extension Tubing	Apogee, Inc.	DXT	Class II	1995-03-17
K935540	Pari-Master Modification	Pari Holding Co.	CAF	Class II	1995-03-17
K930929	Esophageal Stethoscope	Coast Medical Corp.	BZT	Class II	1995-03-17
K920849	Trip Cic Catheter	Tonometrics, Inc.	FFT	Class I	1995-03-17
K951086	Nezhat-Dorsey Hydro-Dissection System and Accessories	American Hydro-Surgical Instruments, Inc.	GCJ	Class II	1995-03-16
K951060	Karl Storz Koh Needle Holders, Forceps for Suturing, Suture Scissors, Tissue Probes, Injection Needle, Irrigation Instrn	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-03-16
K950858	Aurolite 55	Argen Precious Metals, Inc.	EJT	Class II	1995-03-16
K950232	Laparoscope and Accessories for Ob/gyn	OLYMPUS Corporation of the Americas	HET	Class II	1995-03-16
K946205	Cardiovit at-1, P-80	Schiller America, Inc.	DPS	Class II	1995-03-16
K945719	Aspir-Pulse(tm) Arterial Blood Gas (Abg) System	Sherwood Medical Co.	CBT	Class I	1995-03-16
K945042	Elite 3 Low Air Loss Bed	Pegabus Egerton, Ltd.	FNL	Class II	1995-03-16
K945041	Paragon Portable	Pegabus Egerton, Ltd.	FNM	Class II	1995-03-16
K944020	Airsep Newlife Air Outlet Option	Airsep Corp.	CAF	Class II	1995-03-16
K943992	Silclear Tubing	Degania Silicone, Inc.	FPK	Class II	1995-03-16
K943204	Vistacam	Air Techniques, Inc.	EIA	Class I	1995-03-16
K940759	Forte Es	Chattanooga Group, Inc.	GZI	Class II	1995-03-16
K951048	Rite-Bite Biopsy Forceps	Mill-Rose Laboratory	FCL	Class I	1995-03-15