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 2094 of 3531

510(k) clearances, page 2094 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950446	Bone Cutting Instrument and Accessories	Steri-Oss, Inc.	DZE	Class II	1995-05-03
K950387	Gemini	Spegas Industries, Ltd.	CCK	Class II	1995-05-03
K950210	Ccs Maestro(r) II Series 200 Models 235 and 227 Cardiac Pacemaker	Cardiac Control Systems, Inc.	DXY	Class III	1995-05-03
K946156	Depuy Compression Hip Screw System	Depuy, Inc.	KTT	Class II	1995-05-03
K945845	Micos Micropulse(tm) or Table Patient Support	Micos Medical Systems	FNM	Class II	1995-05-03
K945191	Endoscopic Accessory	Un-I-Med, Inc.	FAS	Class II	1995-05-03
K945185	Cystoscope (78Faj)endoscope,fiberoptic (78Gdb)	Karl Storz Endoscopy-America, Inc.	FBO	Class II	1995-05-03
K944978	Bennett X-Ray Digital Spot Imaging System Model M-Dsi	Bennett X-Ray Corp.	IZH	Class II	1995-05-03
K943938	Mityvac Super M Style Vacum Extractor, Disposable	Neward Enterprises, Inc.	HDB	Class II	1995-05-03
K943124	Heartrak	Universal Medical, Inc.	DXH	Class II	1995-05-03
K943123	Pacetrak	Universal Medical, Inc.	DXH	Class II	1995-05-03
K942593	Oxychek Oxygen Analyzer	Nidek Medical Products Inc	CCL	Class II	1995-05-03
K941815	Isotron III	Excel Tech., Ltd.	LIH	Class II	1995-05-03
K941802	Or Towel	Hermitage Hospital Products, Inc.	KKX	Class II	1995-05-03
K941126	Qct-Bone Mineral Analysis Phantom	Image Analysis, Inc.	KGI	Class II	1995-05-03
K940951	Rw Resucitaire Infant Radiant Warmer	Air-Shields, Inc.	FMT	Class II	1995-05-03
K936009	Ams 3000M	Acutronic Medical Systems AG	CAP	Class II	1995-05-03
K925581	Baxter Biostat 1000 Urea Monitor	Baxter Healthcare Corporation	KXM	Class II	1995-05-03
K925469	Jj Skinner Carekits(tm) Dialysis On/off Kit	J.J. Skinner, Inc.	FKG	Class I	1995-05-03
K951638	Auraflex Ck-Mb 200Test Pack, Calibrator Pack	bioMerieux, Inc.	JHY	Class II	1995-05-02
K951511	Tytin Admix	Kerr Corporation (Danbury)	EJJ	Class II	1995-05-02
K951435	Aalto Scientific Sweat Chloride Reference Material	Aalto Scientific Ltd.	JJR	Class I	1995-05-02
K951360	Estradiol Assay for the Technicon Immuno 1 System in-Vitro Diagnostic System	Bayer Corp.	CHP	Class I	1995-05-02
K951183	In-Ceram Spinell	Vident	EIH	Class II	1995-05-02
K951133	Cedia Dau Propoxyphene Assay	Microgenics Corporation	JXN	Class II	1995-05-02
K951016	Disposable Prophylaxis Angle	Preventive Technologies, Inc.	EHK	Class I	1995-05-02
K951008	Power Rangers Sunglasses	Siegel,Mandell & Davidson,P.C.	HQY	Class I	1995-05-02
K950921	Chemiluminescence Tsh 3Rd Generation Immunoassay	Nichols Institute Diagnostics	JLW	Class II	1995-05-02
K950761	Index Acetabulat Component	Zimmer GmbH	JDI	Class II	1995-05-02
K950520	Burr, Corneal, Battery-Powered	Apyx Medical Corporation	HOG	Class I	1995-05-02
K950445	Visualine II Cannabinoids (Thc)	Sun Biomedical Laboratories, Inc.	LDJ	Class II	1995-05-02
K950388	Polaris	Spegas Industries, Ltd.	CCK	Class II	1995-05-02
K950292	Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System	Miles, Inc.	CGN	Class II	1995-05-02
K950280	Tdx(r)/tdxflx(r) Free Phenytoin II	Abbott Medical	MOJ	Class II	1995-05-02
K946364	E Test for Ofloxacin	Ab Biodisk	JWY	Class II	1995-05-02
K946250	Strato Medical Infuse-a-Cath, Triple Lumen Polyurethane, Central Vnous Catheter Systems	Strato Medical Corp.	LJS	Class II	1995-05-02
K946192	Hichem Y-Gt Reagent Kit	Hichem Diagnostics	JQB	Class I	1995-05-02
K945510	Fx-4 Nms (4Channel Table Model)	Fx-2	IPF	Class II	1995-05-02
K945509	Fx-2 Nms (2Channel Table Model)	Fx-2	IPF	Class II	1995-05-02
K945508	Fx-2P Nms (2 Channel Portable)	Fx-2	IPF	Class II	1995-05-02
K945115	Mallory-Head Modular Calcar Repacement Components	Zimmer GmbH	JDI	Class II	1995-05-02
K944692	C-Series Homepump	Block Medical, Inc.	FPA	Class II	1995-05-02
K943978	Waters Pico Tag Chem Pack/free Amino Acid Analysis	Waters Chromatography Division	JJF	Class I	1995-05-02
K942784	Norfolk Omega Port-Lp Subcutaneously Implanted	Norfolk Medical Products, Inc.	LJT	Class II	1995-05-02
K940811	Braintrace	Brainstorms Monitoring Corp.	OLT	Class II	1995-05-02
K940483	2.3 Mm Disposable Neuroview Endoscope	Neuro Navigational Corp.	HRX	Class II	1995-05-02
K935598	Plasma Fibrinogen Control Level 1/Level 2	Clinical Controls, Inc.	GIL	Class II	1995-05-02
K934066	Nephretect	Alden Scientific, Inc.	JOJ	Class II	1995-05-02
K912521	Dental Implant System 4.0Mm and 5.5Mm Length	Bud Industries, Inc.	DZE	Class II	1995-05-02
K951411	Monoject Tuohy Point Epidural Needle (22G X 3 1/2)	Sherwood Medical Co.	BSP	Class II	1995-05-01