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 1299 of 3531

510(k) clearances, page 1299 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052895	Foursight Viewtool Image Viewer	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2005-10-27
K052783	Modification to: Iq Guide Wire, Models 38950-Xx. 38951-Xx	Boston Scientific Corporation	DQX	Class II	2005-10-27
K052754	Wrist Fusion Plate	Dvo Extremity Solutions, LLC	LXT	Class II	2005-10-27
K052721	Minxray, Model Hf100h+	Minxray Inc	IZL	Class II	2005-10-27
K052718	V40 Biolox Delta Ceramic Femoral Heads	Howmedica Osteonics Corp	LZO	Class II	2005-10-27
K052685	Orthopedic Salvage System- Oss	Zimmer GmbH	KRO	Class II	2005-10-27
K052558	Vcs, Model S4t	Cycling and Health Tech. Industry R&D Center/Chc	INI	Class II	2005-10-27
K052262	Quanta Lite M2 Ep (Mit3) Elisa	Inova Diagnostics, Inc.	DBM	Class II	2005-10-27
K052191	Modification to Cellsearch Circulating Tumor Cell Kit	Veridex, LLC	NQI	Class II	2005-10-27
K051871	Stoma Bone Screw	Storz AM Mark GmbH	DZL	Class II	2005-10-27
K051248	Vygon Micro-Access Safety Introducer Kit	Vygon Corp.	DYB	Class II	2005-10-27
K043383	N-Do Endoinjector Needle, Model Ph00961109 and Ph00961110	Physion, Inc.	FBK	Class II	2005-10-27
K043341	Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories Inc.	NVI	Class II	2005-10-27
K052884	Model Dfp-8000D/fpd Digital Radiography System with Flat Panel Detector	Toshiba America Medical Systems, In.C	OWB	Class II	2005-10-26
K052849	Infrared Thermometer, Fdir-V1	Famidoc Technology Co., Ltd	FLL	Class II	2005-10-26
K052714	Rave Composite Bracket	FDA Agents	DYW	Class II	2005-10-26
K052346	Synergies Plus Gram-Positive Mic/combo Panels	Siemens Healthcare Diagnostics Inc.	LON	Class II	2005-10-26
K052073	Futurapress Lt, N and Hp, Futurajet, Futuraself, Futuragen and Futuracryl 2000	Schutz-Dental GmbH	EBI	Class II	2005-10-26
K051727	Aimstick Urine Reagent Strips	Germaine Laboratories, Inc.	CEN	Class I	2005-10-26
K051721	Global Resurfacing Unicompartmental Knee System	Global Orthopaedic Technology, USA, Inc.	HRY	Class II	2005-10-26
K051089	Gii Spinal Fixation System	Co-Ligne AG	MNH	Class II	2005-10-26
K050689	Surgical Face Mask	China Surgical Dressings Center Co.,Ltd	FXX	Class II	2005-10-26
K052893	Atricure Transpolar System	AtriCure, Inc.	GEI	Class II	2005-10-25
K052859	Aquamantys Pump Generator System	Medtronic Navigation, Inc	GEI	Class II	2005-10-25
K052543	Heraceram Zirkonia	Kulzer GmbH	EIH	Class II	2005-10-25
K052416	Peripro Patch	Hancock/Jaffe Laboratories	DXZ	Class II	2005-10-25
K052041	Collagen Bone Healing Protective Sheet	Collagen Matrix, Inc	HRS	Class II	2005-10-25
K052000	Architect Ca 19-9Xr Assay	Fujirebio Diagnostics, Inc.	NIG	Class II	2005-10-25
K051656	Oct (Osteochondral Transplant) Comprehensive System	Osteobiologics, Inc.	HRX	Class II	2005-10-25
K051587	Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470	Tracoe Medical GmbH	BTO	Class II	2005-10-25
K051452	Sentinel Clin Chem Cal	Sentinel CH SpA	JIX	Class II	2005-10-25
K050460	Gyrus Plasmacision and Plasmablend Electrodes	Gyrus ACMI, Inc.	GEI	Class II	2005-10-25
K050394	Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/mdma, Methadone, Opiates, Phencyclidine & Cannabinoids	MEDTOX Diagnostics, Inc.	DKZ	Class II	2005-10-25
K052563	Inogen Satellite Conserver, Model Sc-100	Medical Electronic Devices, Inc.	NFB	Class II	2005-10-24
K052361	Simulix-Evolution with Oncentra Conebeam	Nucletron BV	KPQ	Class II	2005-10-24
K051548	Irradia Mid - Laser (S3)	Irradia AB	ILY	Class II	2005-10-24
K051214	Aluma Skin Renewal System	Lumenis Ltd	GEI	Class II	2005-10-24
K052857	Electrosurgical Generator System, Model Es 3000	Senorx, Inc.	GEI	Class II	2005-10-21
K052746	Concorde Vbr Spinal System	DePuy Spine, Inc.	MQP	Class II	2005-10-21
K052734	Modification to: Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2005-10-21
K052652	Smith & Nephew Continuous Loop Fixation Device	Smith & Nephew, Inc.	GAT	Class II	2005-10-21
K052631	Super Quickanchor Plus (with Orthocord Suture)	DePuy Mitek, Inc.	JDR	Class II	2005-10-21
K052609	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2005-10-21
K052501	Multiple Resin Tooth Bonding Agent	Cosmedent, Inc.	KLE	Class II	2005-10-21
K052349	Avante LED Curing Unit, Model N44	Pentron Clinical Technologies	EBZ	Class II	2005-10-21
K052294	Shoulder Nail Plate	Hand Innovations, Inc.	HRS	Class II	2005-10-21
K052292	Spider Cervical Plating (Scp) System	Xtant Medical Holdings, Inc.	KWQ	Class II	2005-10-21
K052286	Deutsch Anti-Blockage Wound Drain	The Catheter Exchange, Inc.	GBX	Class I	2005-10-21
K052178	Depuy Cas Hip Instrumentation	Depuy Orthopaedics Inc.	HAW	Class II	2005-10-21
K052161	Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)	ZOLL Medical Corporation	MKJ	Class III	2005-10-21