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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2578 of 3530

510(k) clearances, page 2578 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895091	Ria (Condom)	La Technology Sdn. Bhd.	HIS	Class II	1990-01-16
K894510	Biofeedback Electroencephalograph/electromyograph	Capscan Corp.	HCC	Class II	1990-01-16
K893579	Fitc Murine Monoclonal Anti-Influenza Type a	Whittaker Bioproducts, Inc.	GNX	Class I	1990-01-16
K900042	Fortress Buddy Front Wheel Drive Scooter	Fortress Scientific, Ltd.	INI	Class II	1990-01-12
K900041	Fortress Liberator Rwd Scooter	Fortress Scientific, Ltd.	INI	Class II	1990-01-12
K900040	Fortress Spirit Power Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1990-01-12
K900039	Fortress Victory Power Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1990-01-12
K900038	Fortress 760Fs Power Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1990-01-12
K900037	Fortress 755Fs Pediatric Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1990-01-12
K897094	Modified Spiroscan 1000	Fukuda Denshi USA, Inc.	BZG	Class II	1990-01-12
K897028	Lincoln Mills Foot and Leg Holder	Lincoln Mills, Inc.	FWZ	Class I	1990-01-12
K897019	Handi Porch Elevator	The Cheney Co.	ING	Class II	1990-01-12
K896773	Disposable Face Mask	Cadema Medical Products, Inc.	BYG	Class I	1990-01-12
K896628	Liberty Special and Liberty Stairlifts	The Cheney Co.	ILK	Class II	1990-01-12
K896508	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1990-01-12
K896428	Sempermed Latex Examination Gloves	Semperit Industrial Products	LYY	Class I	1990-01-12
K896309	Magnaview m.r.i. Versions 110Fh & 110Fm W/cardiac	Instrumentarium Imaging, Inc.	LNH	Class II	1990-01-12
K896031	Amniotic Fluid Sampler (Amniocentesis Tray)	Concord/Portex	HIO	Class I	1990-01-12
K896029	Digital Ultrasound Imaging System Dub 20	G.W.B. Intl., Ltd.	IYO	Class II	1990-01-12
K895697	Vac Fix(r) System	S&S Par Scientific	IYE	Class II	1990-01-12
K894779	Lifecare Nasal Mask Kit Cat. No. 06-800	Lifecare Services, Inc.	BYE	Class II	1990-01-12
K894755	Astra Disposable Spray Cannula	Astra Pharmaceutical Products, Inc.	CCT	Class II	1990-01-12
K894162	Optisol	Chiron Ophthalmics	LYX	Unclassified	1990-01-12
K896864	Follicle Stimulating Hormone-Eia-Xt	In Vitro Diagnostics, Inc.	CGJ	Class I	1990-01-11
K896861	Opus Phenobarbital Test System	Pb Diagnostic Systems, Inc.	DLZ	Class II	1990-01-11
K896835	Alcohol Prep and Povidone-Iodine Prep	Norpak Mfg., Inc.	LKB	Unclassified	1990-01-11
K896822	Surgismoke	Spectro Industries, Inc.	FYD	Class II	1990-01-11
K896754	I/a Handpiece	Advanced Surgical Products, Inc.	HQE	Class II	1990-01-11
K896705	Visitec Micro-Sponge Spears	Visitec Co.	HOZ	Class II	1990-01-11
K896681	Soft Corneal Light Shield	Visitec Co.	HOY	Class I	1990-01-11
K896626	Hand Controlled Electrosurgical Pencils	Conmedcorp	GEI	Class II	1990-01-11
K896572	Rep(tm) Spe Plus-30 Procedures	Helena Laboratories, Corp.	CFP	Class I	1990-01-11
K896454	Chemstrip(r) 10 with Sg Urine Test Strips	Boehringer Mannheim Corp.	JIL	Class II	1990-01-11
K896333	Cms IV Filters	Vygon Mfg	FPB	Class II	1990-01-11
K896320	Centurion Kleen-Needle System	Centurion Medical Products, LP	FMI	Class II	1990-01-11
K896179	Sked Flotation System	Skedco, Inc.	FPP	Class I	1990-01-11
K896177	Sked Stretcher	Skedco, Inc.	FPP	Class I	1990-01-11
K896161	Avi Model 2012, 1.2 Micron Filter IV Administra.	3M Company	FPA	Class II	1990-01-11
K896049	35 Watt Surgical Carbon Dioxide Laser System	Pfizer Laser Systems	GEX	Class II	1990-01-11
K896046	Vitapatch Cath. Securement Device W/chlorhexidine	Vitaphore Corp.	KMK	Class I	1990-01-11
K896000	Aspartate Aminotranferase (Ast)	American Monitor Corp.	CIT	Class II	1990-01-11
K895999	Phosphorus	American Monitor Corp.	CEO	Class I	1990-01-11
K895993	Vitapatch Antimicrobial Catheter Securement Device	Vitaphore Corp.	KMK	Class I	1990-01-11
K895952	Triglycerides Test Kit	Elite Technology, Inc.	CDT	Class I	1990-01-11
K895900	Wilson-Cook Biliary and Gastric Aspiration Needle	Wilson-Cook Medical Inc.	FCK	Class II	1990-01-11
K895842	Bitome(tm) Bipolar Sphincterotome	Everest Medical Corp.	KNS	Class II	1990-01-11
K895717	Sodium and Potassium Standard	Data Medical Associates, Inc.	JIX	Class II	1990-01-11
K895674	Medicool, Container for Storing Insulin	Medicool, Inc.	LDQ		1990-01-11
K895461	Wellcolex Colour Shigella Test Zc51	Wellcome Diagnostics	GNB	Class II	1990-01-11
K895405	Amicon Minifilter Plus Hemofilter	Amicon, Inc.	KDI	Class II	1990-01-11