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 2364 of 3531

510(k) clearances, page 2364 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920202	Latex Exam/surgical Gloves	Redsun Latex, Ltd.	LYY	Class I	1992-07-23
K915756	Biotrack Carbamazepine Test Cartridge	Biotrack, Inc.	KLT	Class II	1992-07-23
K915755	Biotrack Phenytoin Test Cartridge	Biotrack, Inc.	DIP	Class II	1992-07-23
K915608	Bicut	Berchtold Holding GmbH	GEI	Class II	1992-07-23
K915219	Urethral Electrode Sheath	Applied Urology, Inc.	FAS	Class II	1992-07-23
K913302	Disposable Specialty Sponges (Dissectors)/modified	Carwild Corp.	GDY	Class I	1992-07-23
K922490	Abbott Strep a Controls	Abbott Medical	GTY	Class I	1992-07-22
K923325	Model 600 Medical Treatment Table	Tri W-G, Inc.	INQ	Class I	1992-07-21
K923095	Kaye Model Kiao Pelvic/thigh Stabilizer	Kaye Products, Inc.	INN	Class I	1992-07-21
K923021	Aia-1200Dx - Automated Enzyme Immunoassay System	Tosoh Corp.	KHO	Class I	1992-07-21
K922784	Synermed Uibc Reagent Kit	Synermed, Inc.	JMO	Class I	1992-07-21
K922659	General Surgery Clamp and Needle Holder	Miltex Instrument Co.	GDJ	Class I	1992-07-21
K922158	Protector Syringe Safety Cap System	Injectimed, Inc.	FMI	Class II	1992-07-21
K922150	Examination Lamp	Air-Shields, Inc.	KZF	Class I	1992-07-21
K922139	Vista Immunoassay System -- Modification	Syva Co.	JJE	Class I	1992-07-21
K922138	Vista Ultrasensitive Htsh Assay	Syva Co.	JLW	Class II	1992-07-21
K922125	Stratus Myoglobin Fluorometric Enzyme Immunoassay	Baxter Diagnostics, Inc.	DDR	Class II	1992-07-21
K922121	Sunglasses	Pavilion Investment, Ltd.	HQY	Class I	1992-07-21
K922033	Saline Solution- Sterile	Trinity Laboratories, Inc.	CCQ	Class I	1992-07-21
K922031	Hms Purple and Black Heparin Cartridges & Control	Medtronic Hemotec, Inc.	JOX	Class II	1992-07-21
K921951	Mpg 65-80-100 X-Ray Generator and Control	General Electric Co.	IZO	Class I	1992-07-21
K921856	Total Cross .021 Percut. Transluminal Angio. Cath.	Schneider Intl., Ltd.	LIT	Class II	1992-07-21
K921844	Kodak Ektachem Dt Slides (Nbil)	Eastman Kodak Company	CIG	Class II	1992-07-21
K921718	Olympus Ise Module	Olympus Corp.	JGS	Class II	1992-07-21
K921540	Cooling/heating Therapy Device	Tempacure Home Care	ILO	Class II	1992-07-21
K921495	Dia Strips System, Modified	Symcon Intl., Inc.	JIO	Class II	1992-07-21
K921431	Potty Pager	Ideas for Living	KPN	Class II	1992-07-21
K921249	Wako Autokit Lipase-Color	FUJIFILM Healthcare Americas Corporation	CHI	Class I	1992-07-21
K921201	Vital-Port m.r.i. Dual Lumen Vascular Access Syst.	Med Institute, Inc.	LJT	Class II	1992-07-21
K920844	Pim 1.0 Laser Doppler Perfusion Imager	Lisca Development AB	DPW	Class II	1992-07-21
K920430	Modular Acetabular Cup System	Smith & Nephew Richards, Inc.	JDI	Class II	1992-07-21
K920248	Model Slase 210 Holmium Laser System	Sunrise Technologies, Inc.	GCX	Class II	1992-07-21
K920198	Glycomat Haemoglobin Analyser	Drew Scientific, Ltd.	LCP	Class II	1992-07-21
K920071	Meditron Automatic Electronic Insuff. Model Aei-15	Medical Devices Inc.	GEI	Class II	1992-07-21
K915738	Excel CT Twin	Elscint, Inc.	JAK	Class II	1992-07-21
K914136	Coherent Versapulse(tm) 2.1Xe/2.1l Holmi Surg Lase	Coherent Medical Group	GEX	Class II	1992-07-21
K912405	Latex Prophylactic (Condom)	Hevealactics Intl. Sdn Bhd	HIS	Class II	1992-07-21
K923193	Sunrunner Te-777	Pride Health Care, Inc.	INI	Class II	1992-07-17
K922756	Olympus Uric Acid Reagent	Olympus Corp.	KNK	Class I	1992-07-17
K922369	Olympus Albumin Reagent	Olympus Corp.	CIX	Class II	1992-07-17
K922215	Nova 14 Na/k/cl/glu/bun Analyzer	Nova Biomedical Corporation	JGS	Class II	1992-07-17
K922095	Lx 150 Light Source	Welch Allyn Inc	EQH	Class I	1992-07-17
K922080	Genesys II	Philips North America LLC	KPS	Class II	1992-07-17
K921881	Vista Hpq System	Philips North America LLC	LNH	Class II	1992-07-17
K921786	Intramedullary Hip Screw	Smith & Nephew Richards, Inc.	KTT	Class II	1992-07-17
K921458	Tmp Microplating System	Techmedica, Inc.	HRS	Class II	1992-07-17
K921252	Tandem-E Ferritin Calibration Verification Conrol	Hybritech, Inc.	JJX	Class I	1992-07-17
K921221	Sterile/single Use Symblepharon Ring	Storz Instrument Co.	HQN	Class II	1992-07-17
K920793	Philips Dsi System Release 3.2	Philips North America LLC	IZJ	Class II	1992-07-17
K920556	Tandem-E Hcg Calibration Verification Control Set	Hybritech, Inc.	JJX	Class I	1992-07-17