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 2009 of 3531

510(k) clearances, page 2009 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955920	The E Test Ceftizoxime	Ab Biodisk	JWY	Class II	1996-02-22
K955702	Sonata U-01	Electone, Inc.	ESD	Class I	1996-02-22
K955599	Stryker Femoral Canal Sponge & Acetabulum Sponge	Stryker Corp.	GDY	Class I	1996-02-22
K955456	Oes Laparo-Thoraco Videoscope (Rigid)	OLYMPUS Corporation of the Americas	HET	Class II	1996-02-22
K955152	Stockert S3 Ups, Lvl Ctrl Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer	Stoeckert Instrumente	DTW	Class II	1996-02-22
K954969	Polyfin Qr Subcutaneous Infusion Set	Medtronic, Inc.	FPA	Class II	1996-02-22
K954489	Trinity Sleeve(s)	Delphi Consulting Group	JOW	Class II	1996-02-22
K952995	Ati Ethylene Oxide Sterilization Indicator	Pymah Corp.	JOJ	Class II	1996-02-22
K951457	Glucochek Pocketlab	Clinical Diagnostics, Inc.	CGA	Class II	1996-02-22
K960399	Topaz	J.F. Jelenko & Co., Inc.	EJT	Class II	1996-02-21
K960352	Allrap/slip-N-Grip	Dental Disposables Intl., Inc.	EFB	Class I	1996-02-21
K960339	Consensus 22Mm Cocrmo Femoral Head	U.S. Medical Products, Inc.	JDI	Class II	1996-02-21
K960256	Degudent Ls	Degussa AG	EJT	Class II	1996-02-21
K960202	G.e. Sterile Puncture Tray	GE Healthcare	FRG	Class II	1996-02-21
K960201	G.e. Sterile Breast Biopsy/localization Tray	GE Healthcare	FRG	Class II	1996-02-21
K960156	Consensus 32Mm Cocrmo Femoral Head	U.S. Medical Products, Inc.	JDI	Class II	1996-02-21
K960151	Consensus 26Mm Cocrmo Femoral Head	U.S. Medical Products, Inc.	JDI	Class II	1996-02-21
K960141	G.e. Sterile, Standard Biopsy Tray	GE Healthcare	FRG	Class II	1996-02-21
K960122	Alpha-Dent Temporary Crown and Bridge Material	Wallace A. Erickson & Co.	EBG	Class II	1996-02-21
K960011	Endoscopic Needle Driver	United States Surgical, A Division of Tyco Healthc	OCW	Class II	1996-02-21
K955858	N/t Protein Control Sy/l, M and H	Behring Diagnostics, Inc.	JJY	Class I	1996-02-21
K955857	N Protein Standars Sy	Behring Diagnostics, Inc.	CZW	Class II	1996-02-21
K955782	Med-Net Stopcocks	Mednet, Inc.	FMG	Class II	1996-02-21
K955732	Vented Solution Set	Distronic Sterile Products, Inc.	FPA	Class II	1996-02-21
K955709	Winged & Subcutaneous Infusion Sets	Distronic Sterile Products, Inc.	FPA	Class II	1996-02-21
K955688	Rns Sterile, Disposable Standard Biopsy Tray	Contour Fabricators of Florida, Inc.	FRG	Class II	1996-02-21
K955686	Rns, Sterile Disposable Percutaneous Cholangiographic Tray	Contour Fabricators of Florida, Inc.	FRG	Class II	1996-02-21
K955678	Rns Sterile Disposable Puncture Tray	Contour Fabricators of Florida, Inc.	FRG	Class II	1996-02-21
K955531	Arthrocare Bipolar Loop Electrode System	ArthroCare Corporation	FAS	Class II	1996-02-21
K955421	Osteonics N2/vac Packaging Process	Osteonics Corp.	JWH	Class II	1996-02-21
K955394	Sienet Teleradiology Product Line	Siemens Medical Solutions USA, Inc.	LMC	Class II	1996-02-21
K955381	B. Braum Angiographic/angioplasty Kit	B.Braun Medical, Inc.	DXT	Class II	1996-02-21
K955246	Ecogel 200 Ultrasound Gel	Eco-Med Pharmaceuticals, Inc.	ITX	Class II	1996-02-21
K955041	Instent Esophacoil Self-Expanding Stent System	Instent, Inc.	ESW	Class II	1996-02-21
K955038	Stockert S3 Double Head Pump Module	Stoeckert Instrumente	DWB	Class II	1996-02-21
K954479	Dicomview	Heartlab, Inc.	LMD	Class I	1996-02-21
K954277	Astech Peak Flow Meter	Center Laboratories, Inc.	BZH	Class II	1996-02-21
K953881	Spine System Sacral Plate	J.B.S., S.A.	MNH	Class II	1996-02-21
K952884	Noprofile Olbert Catheter System Balloon Dilatation Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1996-02-21
K952238	Vidcas (Video Capture and Archiving Software)	Imaging Concepts, Inc.	LMB	Class I	1996-02-21
K945145	Ria Latex Condom, Nonoxynol-9	Mbf Personal Care Sdn. Bhd.	HIS	Class II	1996-02-21
K960296	4000 Etm	Aspen Laboratories, Inc.	GEI	Class II	1996-02-20
K955620	Prime Cemented Calcar Femoral Stems	Orthopaedic Innovations, Inc.	JDI	Class II	1996-02-20
K955443	Intran Plus	Utah Medical Products, Inc	HFN	Class II	1996-02-20
K955386	Consensus Zirconia Femoral Head	U.S. Medical Products, Inc.	LZO	Class II	1996-02-20
K955131	Medlite Laser System	Continuum Biomedical, Inc.	GEX	Class II	1996-02-20
K953954	Preloaded Soft Tissue Anchor	Linvatec Corporation	MBI	Class II	1996-02-20
K952725	Multicheck	Radiometer America, Inc	GLY	Class II	1996-02-20
K950342	Tritest Reagent Cd3 Fitc/cd19 Pe/cd45 Percp	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1996-02-20
K946055	Tritest Reagent Cd3 Fitc/cd4 Pe/cd45 Percp	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1996-02-20