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 1031 of 3531

510(k) clearances, page 1031 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K094028	Cp-Fiber (Orthofiber)	Cp Medical	GAT	Class II	2010-03-18
K093957	Architect He4, Architect He4 Calibrators and Architect He4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 Sp54-01,	Fujirebio Diagnostics, Inc.	OIU	Class II	2010-03-18
K093912	Arthrex Tibial Graftbolt	Arthrex GmbH	MBI	Class II	2010-03-18
K093792	LED Light Source	Sunoptic Technologies, LLC	FCW	Class II	2010-03-18
K093670	Modification to: Oasys System	Howmedica Osteonics Corp	MNH	Class II	2010-03-18
K093669	Sec Ibf Cage	Innvotec Surgical, Inc.	MAX	Class II	2010-03-18
K093603	Storm-Base 2.0	Karl Storz Endoscopy-America, Inc.	LLZ	Class II	2010-03-18
K093460	Coaguchek Xs Pro System	Roche Diagnostics GmbH	GJS	Class II	2010-03-18
K093419	Ivas 2-10Mm (10 Gauge) Balloon Catheter, Ivas 2-15 Mm(10 Gauge)0705-115-500, Ivas 3-10Mm(8 Gauge)balloon Catheter, Ivas	Stryker Corp.	NDN	Class II	2010-03-18
K092944	Dana Reusable Test Pack for Steam Sterilization	Dana Products, Inc.	FRC	Class II	2010-03-18
K092699	Nomad Sleep System Recorder, Model Pmu800	Neurotronics, LLC	GWL	Class II	2010-03-18
K092565	Digital Retinal Camera Cx-1	Canon Components, Inc.	HKI	Class II	2010-03-18
K092428	Bio-Oss Collagen	Ed. Geistlich Soehne AG Fuer Chemische Industrie	NPM	Class II	2010-03-18
K092363	Softview, Model 2.01	Riverain Technologies	LLZ	Class II	2010-03-18
K092149	Boss Coagulation Device, Model Boss1215, Boss Coagulation Device, Angled Access, Model Bosa1215	Apyx Medical Corporation	GEI	Class II	2010-03-18
K091741	Tina-Quant Ceruloplasmin	Roche Diagnostics GmbH	CHN	Class II	2010-03-18
K091631	Accessnet, Accessmed, Accessrad, Medview	Aspyra, LLC.	LLZ	Class II	2010-03-18
K100572	Versaclose, Model Vc-200-01	Anulex Technologies, Inc.	GAT	Class II	2010-03-17
K100532	Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819	DePuy Mitek, Inc.	HWC	Class II	2010-03-17
K100520	Nipro Biohole Needle with Capick Scab Remover	Nipro Medical Corporation	FIE	Class II	2010-03-17
K100395	Harmony Vled Surgical Lightning System	STERIS Corporation	FST	Class II	2010-03-17
K100035	Model Visulas 532S Laser with the Vite Option	Carl Zeiss Meditec Inc	GEX	Class II	2010-03-17
K093965	Ultraverse 014 and 018 Balloon Dilatation Catheters	C.R. Bard Inc	LIT	Class II	2010-03-17
K093934	Gore Hybrid Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	2010-03-17
K093676	Omnitech Large, Trimed Compression Screw	Trimed Inc	HWC	Class II	2010-03-17
K092558	Wrist Type Blood Pressure Monitor, Hmbpm-005/Kinetik Branded Bpm2 Series	Harvard Medical Devices, Ltd.	DXN	Class II	2010-03-17
K100490	Litepac, Model 682	Clearstream Technologies Ltd.	LIT	Class II	2010-03-16
K100485	Gynecare Tvt Exact Continence System	Ethicon, Inc	OTN	Class II	2010-03-16
K100484	Impix Manta Cervical Interbody Device	Medicrea	ODP	Class II	2010-03-16
K100474	Quicklasedual+, Quicklase810, Quicklase810, Quicklase980, Quicklase980 Model: 3W,5w,3w,5w	Quicklase Limited	GEX	Class II	2010-03-16
K100351	Neuroscout Steerable Guidewire	Cerenovus, Inc.	DQX	Class II	2010-03-16
K093888	Coopdech Endobronchial Blocker Tube	Daiken Medical Co, Ltd.	CBI	Class II	2010-03-16
K093485	Vesiscan	Life-Tech, Inc.	IYO	Class II	2010-03-16
K093066	I5 Digital X-Ray Imaging System, Model I5	Infimed, Inc.	OWB	Class II	2010-03-16
K093044	Oasis MRI System	FUJIFILM Healthcare Americas Corporation	LNI	Class II	2010-03-16
K092825	Apex Spine System 5.50 Mm Titanium Rod & Polyaxial Screw Washer	Spinecraft LLC	KWP	Class II	2010-03-16
K092427	Spinal Guides Pacs (Pacs Medical Imaging Display Workstation)	Albert Davydov Dds PC Professional	LLZ	Class II	2010-03-16
K092352	Scuba Biliary Stent System	Invatec S.p.A.	FGE	Class II	2010-03-16
K092308	Polestar, Model N-30	Medtronic Navigation Israel, Ltd.	LNH	Class II	2010-03-16
K093232	Optiseal Enpath Valved PTFE Peelable Introducer	Great Batch Medical	DYB	Class II	2010-03-15
K093122	Mbcp+	Biomatlante	LYC	Class II	2010-03-15
K092726	Mesh Gps - Large, Small, Sm, Sm Small	Surgical Structures, Ltd.	OQL	Class II	2010-03-15
K091555	Model Td-3252 Blood Glucose Plus Blood Pressure Monitoring System	Taidoc Technology Corporation	NBW	Class II	2010-03-15
K100552	Raystation Version 1.0	RaySearch Laboratories AB (publ)	MUJ	Class II	2010-03-12
K093930	Didget World Reports	Medrad, Inc.	NBW	Class II	2010-03-12
K093881	Trusignal Spo2 Finger Sensor, Trusignal Spo2 Ear Sensor, Trusignal Spo2 Wrap Sensor	GE Healthcare Finland Oy	DQA	Class II	2010-03-12
K093852	Ezlase 3 Laser System	Biolase MG LLC	GEX	Class II	2010-03-12
K093815	Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124	EMD Millipore Corporation	OMG	Class II	2010-03-12
K093795	Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med Accu2010	Actherm, Inc.	FLL	Class II	2010-03-12
K093577	Liquichek Opiate Control	Bio-Rad Laboratories Inc.	DIF	Class I	2010-03-12