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 2026-11-02, 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 2524 of 3531

510(k) clearances, page 2524 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903253	Cancellous Screw	Onyx Medical LLC	HWC	Class II	1990-08-09
K903252	Broad Self-Compressing Plate	Onyx Medical LLC	HRS	Class II	1990-08-09
K903164	Euramark 610 Photometer	Euro-American Marketing Group, Inc.	JJQ	Class I	1990-08-09
K903153	Emit Ethyl Alcohol Assay	Syva Co.	DIC	Class II	1990-08-09
K903147	Chem-Chex-Alt	Streck Laboratories, Inc.	JJX	Class I	1990-08-09
K903120	Argenco 23	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K903119	Argenco 1	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K903103	Synermed Chloride Reagent Kit	Synermed, Inc.	CHG	Class II	1990-08-09
K903100	Innofluor (Tm) Amikacin Reagent Set	Innotron of Oregon, Inc.	KLQ	Class II	1990-08-09
K903070	Serocard Hsv Igg Antibody Test Kit	Disease Detection International, Inc.	LGC	Class II	1990-08-09
K903059	Argenco 18	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K903047	Immumodot Autoimmunity Screening Panel 4	General Biometrics, Inc.	LLL	Class II	1990-08-09
K903025	Roche Isomune- Ck	Roche Diagnostic Systems, Inc.	JHS	Class II	1990-08-09
K903022	Fixation Staple	Onyx Medical LLC	JDR	Class II	1990-08-09
K902938	Immunodot Autoimmunity Screening Panel 3	General Biometrics, Inc.	LLL	Class II	1990-08-09
K902925	Vitek Immunodiagnostic Assay System (Vidas) (Rbg)	Vitek Systems, Inc.	LFX	Class II	1990-08-09
K902904	Argenco 20 (20 CT) Type II Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K902903	Argenco 17 Type II Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K902901	Argenco 16 Type I Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K902900	Argenco M-1 Type II Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K902899	Argenco 10 Type I Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1990-08-09
K902819	Laminectomy Rogeur	Ruggles Corp.	LXH	Class I	1990-08-09
K902748	Serozyme Free T3 Immunoassay	Advanced Magnetics, Inc.	KHQ	Class II	1990-08-09
K902727	Lsf Cemented Femoral Hip	Implant Technology, Inc.	JDI	Class II	1990-08-09
K902720	Affinity Hcg Test System	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1990-08-09
K902712	Osteonics Ps Head and Neck Hip Stem Series	Osteonics Corp.	LZO	Class II	1990-08-09
K902681	Ez-Screen:hcg	Environmental Diagnostics, Inc.	JHI	Class II	1990-08-09
K902569	Precinorm Hdl Cholesterol Control Material for Ref	Boehringer Mannheim Corp.	JJX	Class I	1990-08-09
K902568	Reflotron Hdl Cholesterol Test Tabs	Boehringer Mannheim Corp.	LBR	Class I	1990-08-09
K902566	Biopool Protein C Eid Kit and Bulk Plates	Biopool AB	GGP	Class II	1990-08-09
K902530	Spectrolyse Atiii Kit	Biopool AB	JBQ	Class II	1990-08-09
K902528	Bioclot C Kit	Biopool AB	GGP	Class II	1990-08-09
K902384	Abdominal or C-Section Drape Sheet	Medical Plastics, Inc.	KKX	Class II	1990-08-09
K902287	Rastronics Portarem 20	Rastronics USA, Inc.	EJT	Class II	1990-08-09
K902279	Km-5 Metal Backed Acetabular Cup	Kirschner Medical Corp.	JDI	Class II	1990-08-09
K902246	Amk Universal Femoral Component	Depuy, Inc.	JWH	Class II	1990-08-09
K902158	Titanium/stainless Steel Dental Implant Drill Comp	Impla-Med	DZE	Class II	1990-08-09
K902124	Dowd Catheter	Boston Scientific Corporation	FAH	Class II	1990-08-09
K902098	Cholesterol (Rate) Reagent	Sigma Chemical Co.	CHH	Class I	1990-08-09
K901833	Ce-8 Custom in-the-Ear Hearing Aids	Starkey Laboratories, Inc.	ESD	Class I	1990-08-09
K901449	Vacutainer Plus with Hemogard Closure	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1990-08-09
K900583	Modified Bivona Epistaxis Catheter	Bivona Medical Technologies	EMX	Class I	1990-08-09
K900510	Pertac-Hybrid	Espe GmbH (US)	EBF	Class II	1990-08-09
K896999	Sdl 310 Diagnostic Ultrasound Instrument	Shimadzu Corp.	IYO	Class II	1990-08-09
K896996	Cas (Computerized Analyzer System)	GN Danavox, Inc.	ETW	Class II	1990-08-09
K895978	Chiba Spinal System	Danek Medical, Inc.	KWP	Class II	1990-08-09
K895687	D'plume Xxii Photocoagulator (Epilation Machine)	Carol Block, Ltd.	KCW	Class I	1990-08-09
K903160	Liebel-Flarsheim Series 8000 Bucky,w/non Size Sens	Continental X-Ray Corp.	IXQ	Class II	1990-08-08
K902868	Rubber Sunglasses	Premium Source Merchandising	HQY	Class I	1990-08-08
K902828	Suture Removal Tray	Orion Life Systems, Inc.	LRW	Class I	1990-08-08