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 2558 of 3530

510(k) clearances, page 2558 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900933	Protex Latex Examination Gloves	Seyen Intl., Inc.	LYY	Class I	1990-03-27
K900792	Ristocetin	Medical Diagnostic Technologies, Inc.	GHR	Class II	1990-03-27
K900782	Heparin Control Plasma, for Use in Aptt	Medical Diagnostic Technologies, Inc.	GGC	Class II	1990-03-27
K900714	Zzipp Instant Bovie Cleaner	Grieshaber & Co.	GEI	Class II	1990-03-27
K900693	u.v. Sunlamp (u.v. Light, Dermatologic)	Light Sources, Inc.	FTC	Class II	1990-03-27
K900636	Rexton Pp 142, Pp 142-L	Rexton, Inc.	ESD	Class I	1990-03-27
K900592	Sharplan Model 1055 Sealed CO2 Surgical Laser	Sharplan Lasers, Inc.	GEX	Class II	1990-03-27
K900352	Latex Exam Gloves (Shanghai Rongtong Latex Gloves)	Sinochem (USA), Inc.	LYY	Class I	1990-03-27
K900199	Lasag Microrupter 2 Nd:yag Laser Trabeculoplasty	Lasag AG	HQF	Class II	1990-03-27
K900166	Nidek, Inc. Models Yc-1100 Ophthalmic Lasers	Nidek, Inc.	GEX	Class II	1990-03-27
K900057	Lifecare(r) 175 Infuser	Abbott Medical	FRN	Class II	1990-03-27
K897196	Advance Stopcocks Advance Manifolds	Advance Medical Designs Inc	DTL	Class II	1990-03-27
K897188	Ketac-Cem Maxicap	Espe GmbH (US)	EMA	Class II	1990-03-27
K897181	L.t.c. Percutaneous Endoscopic Gastrostomy Tube	Intl. Medical Marketing, Inc.	FPD	Class II	1990-03-27
K897177	Calibrators, Control Materials, Electrodes & Tube	Nova Biomedical Corporation	JIX	Class II	1990-03-27
K897142	Mesalt Sterile Dressing	Scott Health Care	FRO	Unclassified	1990-03-27
K897137	Rmi Aortic Root/coronary Sinus Pressure Monitoring	Research Medical, Inc.	DTL	Class II	1990-03-27
K897130	Interface - Cavity Liner	Scientific Pharmaceuticals, Inc.	EJK	Class II	1990-03-27
K896938	Epvc Patient Examination Glove	United Orient, Inc.	LYZ	Class I	1990-03-27
K896759	Pb Plus Lead Latex Gloves	Sistem Med-Pro (M) Sdn Bhd	LZC	Class I	1990-03-27
K896401	Micromate 304	Madsen North America, Inc.	EWO	Class II	1990-03-27
K895948	Port-O-Scope(tm)	North American Medical Products, Inc.	EOQ	Class II	1990-03-27
K895838	Brackmann EMG Monitoring System	WR Medical Electronics Co.	ETN	Class II	1990-03-27
K895588	Portable Air Plethysmograph	Life Sciences Manufacturing, Inc.	DSB	Class II	1990-03-27
K894930	Dentec 4000	Dentec, Inc.	ETN	Class II	1990-03-27
K901240	Astel Non-Metal Backed Acetabular Cup for Cemented	Med-Tek Corp.	JDI	Class II	1990-03-26
K901210	Bounder Va Power Wheelchair	21ST Century Scientific, Inc.	ITI	Class II	1990-03-26
K901000	Uro Tex Urinals	Sierra Laboratories, Inc.	EYZ	Class I	1990-03-26
K900823	Isotron 220	Excel Tech., Ltd.	IPF	Class II	1990-03-26
K897153	Cvis Insight Imaging Catheter	Cardiovascular Imaging Systems, Inc.	LYK	Class II	1990-03-26
K897113	Puritan-Bennett Companion 2801 Volume Ventilator	Medtronic, Inc.	CBK	Class II	1990-03-26
K897081	Ansell Conform Green Examination Gloves	Ansell, Inc.	LYZ	Class I	1990-03-26
K891091	Temptek T-1000 Therapeutic Cooling Unit	Temptek, Inc.	ILO	Class II	1990-03-26
K901275	Retinal Taak	Alcon Surgical, Inc.	HQW	Class II	1990-03-23
K901230	Reaads Anti-Sm Test Kit	Biosearch Medical Products, Inc.	LLL	Class II	1990-03-23
K901105	Paramax Alanine Aminotransferase Reagent	Baxter Healthcare Corporation	CKA	Class I	1990-03-23
K901104	Paramax Aspartate Aminotransferase Reagent	Baxter Healthcare Corporation	CIT	Class II	1990-03-23
K901103	Modified Island Snap TENS Disposable Electrode	Empi	GXY	Class II	1990-03-23
K901102	Modified Island Pin TENS Disposable Electrode	Empi	GXY	Class II	1990-03-23
K900889	Magnetic Resonance Diagnostic Device Accessories	Siemens Medical Solutions USA, Inc.	LNH	Class II	1990-03-23
K900885	Fuji Medical Laser Imager	FUJIFILM Healthcare Americas Corporation	LMC	Class II	1990-03-23
K900806	Stratus(r) Ck-Mb Fluorometric Enzyme Immunoassay	Baxter Healthcare Corporation	JHS	Class II	1990-03-23
K900725	Radio Frequency Receiver Subsystem	Myheal Technologies	LNH	Class II	1990-03-23
K900111	Keeler Konan Specular Microscope Sp3300	Keeler Instruments, Inc.	HLI	Class II	1990-03-23
K900081	New Allen Implant	Oculo Plastik, Inc.	HPZ	Class II	1990-03-23
K900080	New Iowa Motility Implant	Oculo Plastik, Inc.	HPZ	Class II	1990-03-23
K897046	Laser Resistant Tracheal Tube	Sheridan Catheter Corp.	CBI	Class II	1990-03-23
K897000	Imagemaster-101(Tm)	Columbia Scientific, Inc.	LLZ	Class II	1990-03-23
K896990	Pharmulator	Acacia, Inc.	LHI	Class II	1990-03-23
K896781	Micro Dau Cocaine Metabolite Test Kit	IMMUNOTECH s.r.o.	DIO	Class II	1990-03-23