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 1874 of 3531

510(k) clearances, page 1874 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964238	Aircast Vena Flow Sterile Disposable Cuffs	Aircast, Inc.	JOW	Class II	1997-09-08
K963354	5 Star Medical Endoscope	Five Star Medical, Inc.	ODF	Class II	1997-09-08
K960527	Logiq 1000 Diagnostic Ultrsound System	GE Healthcare	IYN	Class II	1997-09-08
K972998	Prisma	Siemens Hearing Instruments, Inc.	ESD	Class I	1997-09-05
K972956	Palceram 82Sf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972955	Palceram 56	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972954	Palaurex 78	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972953	Palaurex 76Kf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972952	Aurebond 51	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972951	Hipallaur 51	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972950	Hipallaur 19	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-05
K972737	Causse Piston	Mednet Locator, Inc.	ETB	Class II	1997-09-05
K972735	Total Ossicular Replacement Prosthesis (Torp)	Mednet Locator, Inc.	ETA	Class II	1997-09-05
K972734	Partial Ossicular Replacement Prosthesis (Porp)	Mednet Locator, Inc.	ETB	Class II	1997-09-05
K972534	Alfalloy	Aalba Dent, Inc.	EJS	Class II	1997-09-05
K972533	Vera Solder	Aalba Dent, Inc.	EJS	Class II	1997-09-05
K972453	Xps Straightshot Microresector	Xomed, Inc.	ERL	Class II	1997-09-05
K972210	Resectoscope Safety Sheath	Conceptus, Inc.	HIH	Class II	1997-09-05
K972205	Alpha 7000 Quadrature Wrist Coil	GE Healthcare Coils	MOS	Class II	1997-09-05
K972193	Olympix Mini-Pasteurmatic (58210)	Olympic Medical Corp.	LDS	Class II	1997-09-05
K972178	Unisurge Interface P	Unisurge Holding, Inc.	GCJ	Class II	1997-09-05
K972168	Sidexis Digital Radiography System	KaVo Dental Technologies, LLC	EHD	Class II	1997-09-05
K972163	Imation Se-196 Laser Imager	Imation Corp.	LMC	Class II	1997-09-05
K971919	Ezchek/hba Blood Collection Kit	Flexsite Diagnostics, Inc.	LCP	Class II	1997-09-05
K971492	Automatic Electronic Hysteroscopic Insufflator	Bei Medical Systems Co., Inc.	HIG	Class II	1997-09-05
K971356	Powder Free Synthetic Examination Gloves	Arista Latindo Industrial, Ltd. P.T.	LZA	Class I	1997-09-05
K970808	Medlite IV Q-Switched, Frequency Doubled, Nd:yag Laser	Continuum Biomedical, Inc.	GEX	Class II	1997-09-05
K970468	Kt Air Bed	KCI USA, Inc.	FNM	Class II	1997-09-05
K970464	P Reference Tps (Treatment Planning Software) 1.1	Northwest Medical Physics Equipment, Inc.	IYE	Class II	1997-09-05
K970159	Flex-Neck Pd Catheter	Janin Group, Inc.	FJS	Class II	1997-09-05
K973222	Sc9000/sc9015 Medical Information Bus (Mib) Protocol Converter	Siemens Medical Solutions USA, Inc.	DQA	Class II	1997-09-04
K973030	Vitros Immunodiagnostics Products/ck-Mb Reagent Pack(gem.1300)/ck-Mb Calibrators (Gem.c300)	Johnson & Johnson Clinical Diagnostics, Inc.	JJY	Class I	1997-09-04
K972516	Synthes (USA) Flexible Humeral Nail(flex Nail) System	Synthes (USA) Products LLC	JDS	Class II	1997-09-04
K972441	Radiotherapeutics RF Generator. Model #RF-2000	Radiotherapeutics Corp.	GEI	Class II	1997-09-04
K972367	Stryker System 4000 Heavy Duty Battery Powered Equipment	Stryker Corp.	KIJ	Class I	1997-09-04
K972364	Unicap Phadiatop	Pharmacia, Inc.	DHB	Class II	1997-09-04
K971487	Bkmi Disposable Syringe	Sumi Salud C.A.	FMI	Class II	1997-09-04
K971260	Sullivan Humidaire Heated Humidifier	ResMed Corp	BTT	Class II	1997-09-04
K970627	E. Cam Coincidence Mode (Cm)	Siemens Medical Solutions USA, Inc.	KPS	Class II	1997-09-04
K964815	Ap-4000, Air Pulse Sensory Stimulator	Pentax Precision Instrument Corp.	LLN	Class I	1997-09-04
K972139	Aspr-Care Closed System,dual Swivel Piece T,sheathed Suction Catheter,bronchosope Adapter,in-Line Specimen Trap	Davis & Geck, Inc.	BTM	Class II	1997-09-03
K971717	Fly Through	Siemens Medical Solutions USA, Inc.	JAK	Class II	1997-09-03
K971176	View Archiving Station	Electromed Intl., Ltd.	IZI	Class II	1997-09-03
K971132	Royale Brand Latex Condoms (Silicone)-Colored/assorted Colors	G. Premjee (USA), Inc.	HIS	Class II	1997-09-03
K970835	Face Mask, Surgical Mask, Non-Sterile	Tucker & Associates	FXX	Class II	1997-09-03
K970581	Clinijel	Hospicon Products	HIS	Class II	1997-09-03
K964908	Vrf40 Venous Reservoir with Integral Cardiotomy Filter	Sorin Biomedical, Inc.	DTN	Class II	1997-09-03
K973115	Arripro 35 St/tv	Arnold & Richter Cine Technik	IXC	Class I	1997-09-02
K972720	Follicle Stimulating Hormone (Fsh) Microplate Elisa (425-300)	Monobind, Inc.	CGJ	Class I	1997-09-02
K972663	Smart Set	Top Spins, Inc.	FPA	Class II	1997-09-02