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 1237 of 3531

510(k) clearances, page 1237 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062668	Audit Microcv Immunoassay Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2006-10-16
K062481	Sereno Electronic Stethoscope	Pishon High Tech Co., Ltd.	DQD	Class II	2006-10-16
K062456	Novaspine Powered Suction Pump Pro-1	Novaspine, LLC	OMP	Class II	2006-10-16
K062312	Axiom Pulsed Light System	General Project S.r.l.	GEX	Class II	2006-10-16
K062240	Carevent	Chief Medical, LLC	KNY	Class II	2006-10-16
K062215	Confidant 2.0	Confidant, Inc.	DRG	Class II	2006-10-16
K061876	Codman Vpv System, Model 82-3192	Cerenovus, Inc.	JXG	Class II	2006-10-16
K061428	Pmp4 Application	Card Guard Scientific Survival, Ltd.	MSX	Class II	2006-10-16
K060772	Manuel Saftey Syringe Parts 1 & 2	Medsafe ASA	MEG	Class II	2006-10-16
K052992	Conmed Linvatec Instrument Sterilization Tray	Conmed Linvatec	FRG	Class II	2006-10-16
K052907	Polarcoat	Patton Surgical Corp.	GEI	Class II	2006-10-16
K051968	Abl8x7 Flex	Radiometer Medical ApS	CGL	Class II	2006-10-16
K062972	Precinorm Ck-Mb and Precipath Ck-Mb Controls	Roche Diagnostics GmbH	JJX	Class I	2006-10-13
K062935	Habib 4X Laparoscopic	Boston Scientific Corporation	GEI	Class II	2006-10-13
K062923	Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-13
K062895	Xenon Brightstar Illumination System, Model 1266.Xiii	Dutch Ophthalmic Research Center International BV	MPA	Class II	2006-10-13
K062846	Collagen Dental Membrane III	Collagen Matrix, Inc	NPL	Class II	2006-10-13
K062808	Liquid Stable (Ls) 2-Part Homocysteine Reagent	Catch Incorporated	LPS	Class II	2006-10-13
K062805	Modification to Endo-Ease	Spirus Medical, LLC	FED	Class II	2006-10-13
K062773	Microscan Microstrep Plus Panel, Penicillin	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2006-10-13
K062768	Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium Ti-6Al-4V Alloy Femoral	Zimmer GmbH	JWH	Class II	2006-10-13
K062767	Ctl-63 and Ctl-128 Spine Array Coils	Invivo Corporation	MOS	Class II	2006-10-13
K062742	Cr 85-X	Agfa Corp.	MQB	Class II	2006-10-13
K062697	Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft	Cook Biotech, Inc.	FTL	Class II	2006-10-13
K062696	Surgisis, Surgisis Es	Cook Biotech, Inc.	FTM	Class II	2006-10-13
K062681	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-10-13
K062495	Healos Fx Bone Graft Substitute and Graft Mixing and Delivery System	DePuy Spine, Inc.	MQV	Class II	2006-10-13
K062301	Depuy Lps Proximal Tibial Component	Depuy Orthopaedics Inc.	KRO	Class II	2006-10-13
K062157	Conform	Apex Dental Materials, Inc.	EBF	Class II	2006-10-13
K062097	Veress Cannula and Modular Veress Cannula	Pajunk GmbH Medizintechnologie	HET	Class II	2006-10-13
K061679	Wallace Artificial Insemination Catheter	FUJIFILM Biosciences Inc.	LKF	Class II	2006-10-13
K061544	Stellartech 100 Coagulation System	Stellartech Research Corp.	GEI	Class II	2006-10-13
K061413	Aptima CT Assay on the Tigris Dts System	Hologic, Inc.	MKZ	Class I	2006-10-13
K061070	Hansen Medical Transseptal Needle and Dilator	Hansen Medical, Inc.	DRC	Class II	2006-10-13
K060669	Medrelief St Series, Models Rt-50, St-100, St 150, St-200, St-300	Healthonics, Inc.	GZJ	Class II	2006-10-13
K060158	Net-2000 Microcurrent Stimulator	Auri-Stem Medical, Inc.	QJQ	Class II	2006-10-13
K052229	Coloplast Ostomy Rod, Model 12814	MEDLINE INDUSTRIES, LP - Northfield	EZP	Class II	2006-10-13
K051436	Pre' Vaginal Lubricant	Ingfertlity, LLC	PEB	Class II	2006-10-13
K062927	Microscan Microstrep Plus Panel Ampicillin (0.013 - 16 Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-12
K062144	Escort M8 Vital Signs Patient Monitor, Model 3810	Invivo Corporation	MHX	Class II	2006-10-12
K061847	Zimmer Contour Ceramic Abutment, Models Zra341s, Zra342s, Kra451s, Zra452s	ZimVie US Corp LLC	NHA	Class II	2006-10-12
K061046	Cardiomems Endosure Pressure Sensor with Delivery System, Model Ads-1001 and Interrogator, Model Ems 5001	Cardiomems, Inc.	NQH	Class II	2006-10-12
K061001	Thermassage	Solta Medical, Inc.	GEI	Class II	2006-10-12
K060458	Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent Md10, Manzi Sterilant Ms10, Manzi Chemical Indicator	Langford IC Systems, Inc.	FEB	Class II	2006-10-12
DEN060007	Introl Cf Panel I Control	Maine Molecular Quality Controls, Inc.	NZB	Class II	2006-10-12
K062881	Collagen Dental Menbrane - Conformable II	Collagen Matrix, Inc	NPL	Class II	2006-10-11
K062790	Wu's 3-Wheeled Neo Scooter, Model Wt-T3e	Wu's Tech Co., Ltd.	INI	Class II	2006-10-11
K062727	Cardioblate Navigator Tissue Dissection Device	Medtronic, Inc.	GCJ	Class II	2006-10-11
K062698	Trio + Spinal System	Howmedica Osteonics Corp	MNI	Class II	2006-10-11
K062663	Moldex Health Care N95 Particulate Respirators and Surgical Masks	Moldex/Metric, Inc.	MSH	Class II	2006-10-11