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 1431 of 3531

510(k) clearances, page 1431 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031989	Ortrautek Orthognathic System	Tekka	JEY	Class II	2003-10-28
K033283	Centra View Device Link System	Icu Datasystems, Inc.	MWI	Class II	2003-10-27
K033108	Vivo 200 Dps Vivoscan Version 2.0 Oae Audiometer	Vivosonic Inc.	EWO	Class II	2003-10-27
K032403	Smartmonitor 2 Professional Series (Ps)	Respironics, Inc.	NPF	Class II	2003-10-27
K032099	Swiss Master Light	(Ems Sa) Electro Medical Systems	EBZ	Class II	2003-10-27
K030394	Fluid Sample Retrieval System	Biomed Personal Metabolic and Nutritional Testing	JKA	Class II	2003-10-27
K024322	Embla N7000	Medcare Flaga	MNR	Class II	2003-10-27
K022730	Perfadex Solution for Lung Preservation	Vitrolife Inc.	MSB	Class II	2003-10-27
K033181	Spr System	Radiancy (Israel), Ltd.	GEX	Class II	2003-10-24
K033069	Digital Temperature Monitor, Model Gt-202, Gt-203, Gt-204, and Gt-205	Tenghi Co., Ltd.	FLL	Class II	2003-10-24
K033049	Czr Press	Noritake Co., Inc.	EIH	Class II	2003-10-24
K033024	Modification to Suture Clinch	Applied Medical Resources Corp	FZP	Class II	2003-10-24
K032704	Innovatech Illuminating Laser Probe, Model 420-30	Innovatech Surgical, Inc.	GEX	Class II	2003-10-24
K032703	Innovatech Straight Laser Probe, Model 420-10	Innovatech Surgical, Inc.	GEX	Class II	2003-10-24
K032482	Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System	Stanbio Laboratory	GKR	Class II	2003-10-24
K032433	Nasal Jacks Mask	ResMed Corp	BZD	Class II	2003-10-24
K032419	Quantex D-Dimer	Instrumentation Laboratory Co.	DAP	Class II	2003-10-24
K032348	Converge Reti-Lock Multi-Hole Reinforcement Cup	Centerpulse Orthopedics, Inc.	LZO	Class II	2003-10-24
K032307	Cap Bone Substitute Material	Etex Corp.	GXP	Class II	2003-10-24
K032221	Adept 1064/755 Laser	Adept Medical Concepts	GEX	Class II	2003-10-24
K032220	Adept 1064/532 Laser	Adept Medical Concepts	GEX	Class II	2003-10-24
K032218	Adept 1064/532/755 Laser	Adept Medical Concepts	GEX	Class II	2003-10-24
K032083	Nuvasive Neurovision Jjb System	NuVasive Inc	ETN	Class II	2003-10-24
K031928	Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment)	Braun GmbH	FLL	Class II	2003-10-24
K031750	Safeskin* Blue Zone Powder-Free Vinyl Exam Glove	Kimberly-Clark Corporation	LYZ	Class I	2003-10-24
K031503	Avita Ts8/ts9 Series Ir Ear/forehead Thermometer	Avita Corporation	FLL	Class II	2003-10-24
K033139	Ge Marlin Ultrasound	General Electric Co.	IYN	Class II	2003-10-23
K032996	Elekta Synergy System	Elekta Oncology Systems, Ltd.	IYE	Class II	2003-10-23
K032930	Ultraflex Esophageal Ng Stent System	Boston Scientific Corporation	ESW	Class II	2003-10-23
K032820	Modification to Endoscopic Plication System	Ndo Surgical, Inc.	ODE	Class II	2003-10-23
K032698	Coapt Endotine Midface-St 4.5 Device	Coapt Systems, Inc.	GAM	Class II	2003-10-23
K032576	Biopsy Breast Coil, Model Bbc	Mri Devices Corp.	MOS	Class II	2003-10-23
K032530	Modification to Omnilink .035 Biliary Stent System	Boston Scientific Corporation	FGE	Class II	2003-10-23
K032164	Diabetes Data Management System (Ddms), Model 7333	Medtronic, Inc.	LZG	Class II	2003-10-23
K030627	Orbiter Pv Diagnostic Electrode Catheter, Models 320100 & 320110	C.R. Bard Inc	DRF	Class II	2003-10-23
K030421	Alsius Coolgard 3000 & Alsius Catheter System	Alsius Corp.	NCX	Class II	2003-10-23
K023723	Finometer Noninvasive Hemodynamic Monitor, Model 1	Finapres Medical Systems B.V.	DXN	Class II	2003-10-23
K033254	Forte Gamma Camera System	Philips North America LLC	KPS	Class II	2003-10-22
K032989	Medi-Heat Infant Heel Warmer	Mediheat, Inc.	MPO	Class I	2003-10-22
K032941	Autosound 7.6 Muscle Stimulator, TENS, Therapeutic Ultrasound and Combination Device	Rich-Mar Corp.	IPF	Class II	2003-10-22
K032931	Pta Balloon Catheter	Cook Inc.	DQY	Class II	2003-10-22
K032929	Modification To:xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822	Abbott Vascular	FGE	Class II	2003-10-22
K032726	Zimmer M/l Taper Hip Prosthesis, 7711 Series	Zimmer GmbH	LPH	Class II	2003-10-22
K032714	Cardicare Model Mt-301F & Mt-301C	Lumiscope Co., Inc.	FLL	Class II	2003-10-22
K032686	Ascension Modular Radial Head	Ascension Orthopedics, Inc.	KWI	Class II	2003-10-22
K032682	Sts Screw	Ortho-Pro, LLC	HWC	Class II	2003-10-22
K032632	Remote Access Perfusion Cannula Left Axillary 21 French	Estech, Inc.	DWF	Class II	2003-10-22
K032590	Microplex Coil System (Mcs), Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2003-10-22
K032580	Protege Gps Self-Expanding Nitinol Stent and Delivery System	Medtronic, Inc.	FGE	Class II	2003-10-22
K032565	Cynosure Photogenica Vl	Cynosure, LLC	GEX	Class II	2003-10-22