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 1384 of 3531

510(k) clearances, page 1384 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040930	Zilver Biliary Stent System Usw	Wilson-Cook Medical Inc.	FGE	Class II	2004-07-02
K040498	Myshell	Sedat S.A.	DTL	Class II	2004-07-02
K040416	Sonicare Advance Toothbrush, Model 4900	Philips Oral Healthcare, LLC	JEQ	Class I	2004-07-02
K033949	Varilux Visionprint System (Vps)	Essilor Intl.	HLL	Class II	2004-07-02
K041681	Atricure Dissector	AtriCure, Inc.	FTD	Class II	2004-07-01
K041656	Modification to Depuy 1 Gentamicin Bone Cement and Smartset Gmv Endurance Gentamicin Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2004-07-01
K041641	Davol Delivery System	C.R. Bard Inc	GCJ	Class II	2004-07-01
K041556	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-07-01
K041494	Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 2	Olympus Corp.	FET	Class II	2004-07-01
K041466	Titanium Femoral Knee Components (Maxim and Agc)	Biomet Manufacturing Corp	JWH	Class II	2004-07-01
K041460	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	KWQ	Class II	2004-07-01
K041459	Lifepak 12 Defibrillator/monitor	Physio Control, Inc.	MKJ	Class III	2004-07-01
K041449	Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat	Interpore Cross Intl.	KWP	Class II	2004-07-01
K041446	Nasalcease	Les Laboratorires Brothier, S.A.	EMX	Class I	2004-07-01
K041302	Refuge Sound Generator	Micro-Ear Technology, Inc.	KLW	Class II	2004-07-01
K041209	Resmed S8 Pioneer CPAP System	ResMed Corp	BZD	Class II	2004-07-01
K041106	Revision Knee System	Smith & Nephew, Inc.	JWH	Class II	2004-07-01
K041092	Fast Start TENS, Model Fs 3001	Vision Quest Industries, Inc.	GZJ	Class II	2004-07-01
K041081	Fragment Plate System, Screws, Pins and K-Wires	Hand Innovations, Inc.	KTT	Class II	2004-07-01
K041001	Omega 2 System	Howmedica Osteonics Corp	KTT	Class II	2004-07-01
K040986	Cadwell Limb Movement Module	Cadwell Laboratories, Inc.	LEL	Class II	2004-07-01
K040946	Ankylos Dental Implant System	Friadent GmbH	DZE	Class II	2004-07-01
K040938	Radial Nail System	Wrightmedicaltechnologyinc	HRS	Class II	2004-07-01
K040932	Easynet Body Position Module	Cadwell Laboratories, Inc.	LEL	Class II	2004-07-01
K040907	Arthrex Small Fragment Plates and Screws	Arthrex GmbH	HRS	Class II	2004-07-01
K040576	Micromesam Basic-Set	Map Medizintechnik Fur Arzt und Patient GmbH	MNR	Class II	2004-07-01
K040438	Powerheart AED G3a	ZOLL Medical Corporation	MKJ	Class III	2004-07-01
K040155	Peripheral Cutting Balloon	Boston Scientific Corporation	PNO	Class II	2004-07-01
K040096	Spinal Concepts, Inc. Tandem Spinous Process Plate System	Spinal Concepts, Inc.	KWP	Class II	2004-07-01
K033959	Lps	Depuy, Inc.	JWH	Class II	2004-07-01
K033951	Radix Cervical Plate	Pisharodi Surgicals, Inc.	KWQ	Class II	2004-07-01
K033826	Orthopedic Alliance Spine System	Orthopedic Alliance, LLC	MNI	Class II	2004-07-01
K032937	Navigant Magnetic Navigation Workstation 2.1 (Nws2) Model, 020-004500	Stereotaxis Inc	DXX	Class II	2004-07-01
K022823	Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520	Geister Medizin Technik GmbH	MGZ	Class II	2004-07-01
K041686	Bair Hugger Temperature Management System	Arizant Healthcare, Inc.	DWJ	Class II	2004-06-30
K041605	Precision Rxi Analog X-Ray System	General Medical Merate S.p.A.	OWB	Class II	2004-06-30
K041569	Clear100 Phototherapy System, Model Fgcm0002	Curelight, Ltd.	GEX	Class II	2004-06-30
K041550	Hospira Phoenix Infusion System with Hospira Mednet Software	Abbott Medical	FRN	Class II	2004-06-30
K041545	Contact Detach	Unomedical A/S	FPA	Class II	2004-06-30
K041309	Imask Tm	Vital Signs, Inc.	BZD	Class II	2004-06-30
K041052	Raichem Glucose UV (Liquid)	Hemagen Diagnostics, Inc.	CFR	Class II	2004-06-30
K041051	Raichem Bun Rate Reagent (Liquid)	Hemagen Diagnostics, Inc.	CDQ	Class II	2004-06-30
K041030	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2004-06-30
K040862	Guardian Neonate Cpap/humidification System	Caradyne, Ltd.	BZD	Class II	2004-06-30
K040854	West Nile Virus Igm Capture Elisa	Focus Technologies, Inc.	NOP	Class II	2004-06-30
K040674	Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles	Anthogyr	EFA	Class I	2004-06-30
K040663	Telenable Ems System	Molex, Inc.	DRG	Class II	2004-06-30
K040364	Medpor Craniofacial Implants with Embedded Titanium Mesh	Porex Surgical, Inc.	FTM	Class II	2004-06-30
K034043	H-Flow Valve	Elcam Medical A.C.A.L.	DQO	Class II	2004-06-30
K033984	Straumann Dental Implant System	Straumann USA, LLC	DZE	Class II	2004-06-30