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 2435 of 3531

510(k) clearances, page 2435 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910828	Landers Wide Field Temporary Keratoprosthesis	Ocular Instruments, Inc.	MLP	Class II	1991-08-21
K910676	Intraoral Dental Wax	Pemaco, Inc.	EGD	Class I	1991-08-21
K905040	Alginate Fiber	Shepherd Medical Corp.	FRO	Unclassified	1991-08-21
K913051	Spectral EEG Monitor Model B500	Biometrak Corp.	OLT	Class II	1991-08-20
K912875	Avi Model 270Ci Infusion Pump	3M Avi, Inc.	FRN	Class II	1991-08-20
K912853	Plp Evacuation Control System 1 Micro (Ecs.1um)	Precision Laser Products, Inc.	FYD	Class II	1991-08-20
K912721	Aurofilm Mp	Metalor Dental USA Corp.	EJT	Class II	1991-08-20
K912720	Endo-Core	Metalor Dental USA Corp.	ELR	Class I	1991-08-20
K912708	Clearfil Photo Anterior & Liner Bond System	Kuraray Co.	EBF	Class II	1991-08-20
K912707	Clearfil Liner Bond System	Kuraray Co.	KLE	Class II	1991-08-20
K912566	Minitrop Aerosol Unit	Heyer America, Inc.	CAF	Class II	1991-08-20
K912493	Degubond Lite	Degussa AG	EJS	Class II	1991-08-20
K912266	Modification Axiom Total Knee Syst, Patellar Comp	Orothmet, Inc.	JWH	Class II	1991-08-20
K912197	Skin Saver(tm) Tubing Holder, Model 467	Alpine Specialties, Inc.	CAT	Class I	1991-08-20
K912078	Sarns Sm03 Membrane Oxygenator, Modification	3M Health Care, Sarns	DTZ	Class II	1991-08-20
K912052	Heart Cath Tray	Medical Device Inspection Company	FSM	Class I	1991-08-20
K912032	Silon(tm) Transparent Wound Dressing	Bio Med Sciences, Inc.	MGP	Unclassified	1991-08-20
K911789	Minimax (Tm) Hardshell Venous Res W/inte Card Filt	Medtronic, Inc.	DTP	Class II	1991-08-20
K911749	L-Linex-Ray Fluorescence	Montifore Medical Center	JAO	Class II	1991-08-20
K911165	Screw, Bone, Maxillofacial	Tekno-Medical	DZL	Class II	1991-08-20
K904625	Synectics Liberty System, Pc Polygraf and Polygram	Synectics-Dantec	BZG	Class II	1991-08-20
K904290	Nozovent, Nasal Dilator	Wpm Intl AB Intl Trade & Managemet Consulting	LWF	Class I	1991-08-20
K900205	Drainage Catheters W/a Dissolvable Tip	Boston Scientific Corporation	FGE	Class II	1991-08-20
K912284	Biovision Endocular Probe Access Deliv Syst, Modif	Douglas James Donaldson Compliance Services	GEX	Class II	1991-08-19
K912245	Agc Revision Knee Prothesis	Zimmer GmbH	JWH	Class II	1991-08-19
K912010	i.v. Sky-Hook	Dina - Industria, Comercio E Exportacao, Ltd.	FOX	Class I	1991-08-19
K911290	Eagle Nuclear Imaging System	Trionix Research Laboratory, Inc.	KPS	Class II	1991-08-19
K911263	22Mm Id/od Adapter	Monaghan Medical Corp.	CAI	Class I	1991-08-19
K911257	Mr-5200 Full Disclosure System	Mennen Medical, Inc.	DSH	Class II	1991-08-19
K910342	Sonoace 4500 Diagnostic Ultrasound Imaging System	Medison Co., Ltd.	IYO	Class II	1991-08-19
K905107	Uts Electrical Muscle Stimulation Device-Pgs 1500	Universal Technology Systems, Inc.	IPF	Class II	1991-08-19
K913281	E-Z Clean Laparoscopic Electrode	Megadyne Medical Products, Inc	GEI	Class II	1991-08-16
K913280	Opus(r) Prolactin Test System	Pb Diagnostic Systems, Inc.	CFT	Class I	1991-08-16
K913236	Stratus(r) Hcg Fluorometric Enzyme Immunoassay	Baxter Healthcare Corporation	DHA	Class II	1991-08-16
K913227	Jace Model T300 Toe Cpm Device	Thera Kinetics, Inc.	BXB	Class I	1991-08-16
K913122	Directigen 1-2-3(Tm) Hcg Test	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1991-08-16
K913121	Omniflex Overhead Tubecrane Cat.#s-9108/#6713.400	Continental X-Ray Corp.	KXJ	Class II	1991-08-16
K913120	Polystar Angiographic X-Ray System	Siemens Medical Solutions USA, Inc.	IZI	Class II	1991-08-16
K913112	Opti-Plast 5F Pta Catheters	Vas-Cath, Inc.	LIT	Class II	1991-08-16
K912989	Planustar and Dens Nobilis Denture Teeth	Wilde-USA, Inc.	EMI	Class I	1991-08-16
K912903	Percutaneous Retractor Kit	Applied Urology, Inc.	GCJ	Class II	1991-08-16
K912823	High Density Lipoprotein Cholesterol	Creative Laboratory Products, Inc.	LBR	Class I	1991-08-16
K912654	Omnifit Epf Dual Geometry Acetabular Cup	Osteonics Corp.	MEH	Class II	1991-08-16
K912650	1.1, 1.2, 1.3 Temperature Probes	Vital Signs, Inc.	FLL	Class II	1991-08-16
K912537	Jace Model K200 Knee Cpm Device, Modification	Thera Kinetics, Inc.	BXB	Class I	1991-08-16
K912490	Citation Medical Scope Procedure Pack	Citation Medical Corp.	KKX	Class II	1991-08-16
K912443	Candela Introducer Sheath System	Candela Corporation	FDE	Class II	1991-08-16
K912415	Medical Safety Cable and Lead System	Medtronic, Inc.	BZQ	Class II	1991-08-16
K912365	Tdx(r)/tdxflx(tm) & Adx(r) Propoxphene Assays	Abbott Medical	JXN	Class II	1991-08-16
K912354	Olymous Xls Xenon Light Source	Perkinelmer Optoelectronics	GCT	Class II	1991-08-16