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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 759 of 3530

510(k) clearances, page 759 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141517	Zimmer Plates and Screws (Zps)-Non-Sterile Plates	Zimmer GmbH	HRS	Class II	2014-08-13
K141128	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2014-08-13
K140782	Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator	Celleration, Inc.	NRB	Class II	2014-08-13
K140476	Arthrex Fibertak Suture Anchor	Arthrex GmbH	MBI	Class II	2014-08-13
K140392	3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader	3M Company	FRC	Class II	2014-08-13
K133685	0.9% Sodium Chloride Flush Syringe	Am USA	NGT	Class II	2014-08-13
K130631	Buzzy	Mmj Labs, LLC	PHW	Class I	2014-08-13
K142116	Lld Ez	Spectranetics Corp.	DRB	Class II	2014-08-12
K142021	Elecsys Estradiol III CalSet	Roche Diagnostics GmbH	JIT	Class II	2014-08-12
K141225	Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord	Olympus Winter & Ibe GmbH	GEI	Class II	2014-08-12
K141077	Da Vinci Firefly Imaging System	Intuitive Surgical, Inc.	NAY	Class II	2014-08-12
K140988	Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine)	Hebei Hongsen Plastics Technology Co, Ltd.	KGO	Class I	2014-08-12
K134014	Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)	Remote Diagnostic Technologies Ltd.	MWI	Class II	2014-08-12
K133562	Catarhex 3	Oertli Instrumente AG	HQC	Class II	2014-08-12
K133358	Nidek Multicolor Laser Photocoagulator System Mc-500 Connected with the Endophotocoagulation Delivery Unit	Nidek Co., Ltd.	HQF	Class II	2014-08-12
K133255	Zeramex T and Zeramex Plus Dental Implant Systems	Dentalpoint AG	DZE	Class II	2014-08-12
K131407	Bahadir Sterilization Trays	Bahadir USA LLC	KCT	Class II	2014-08-12
K141983	Neuroblate System	Monteris Medical Corp	GEX	Class II	2014-08-11
K133945	Cutera Picosecond Laser System	Cutera Inc	GEX	Class II	2014-08-11
K141101	Litho	Quanta System Inc.	GEX	Class II	2014-08-08
K141012	Hydrocleanse Wound Care Solution	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2014-08-08
K140886	Walkaide System	Innovative Neurotronics, Inc.	GZI	Class II	2014-08-08
K140381	Sensilight/ Sensilight Plus	El Global Trade Ltd.	OHT	Class II	2014-08-08
K133751	Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2014-08-08
K133712	Embryoviewer Software	Unisense Fertilitech A/S	MQG	Class II	2014-08-08
K133325	Blue Nitrile Powder Free Exam Gloves	Shandong Xinshi Medical Products Co., Ltd.	LZA	Class I	2014-08-08
K121886	Savina 300 Savina 300, Country Variants	Draeger, Inc.	CBK	Class II	2014-08-08
K141992	Variax 2 System	Stryker Trauma GmbH	HRS	Class II	2014-08-07
K141916	Pathassist LED Light Fiber	Entellus Medical, Inc.	LRC	Class I	2014-08-07
K141871	Straumann Bone Level NC Angled Screw Retained Abutments	Straumann USA, LLC	NHA	Class II	2014-08-07
K141870	Breast Volume Navigator	MetriTrack, Inc.	IYN	Class II	2014-08-07
K141846	Acuson X700 Ultrasound System, Acuson X600 Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2014-08-07
K141823	Aap Loqtec Clavicle Plates 2.7/3.5	AAP Implantate AG	HRS	Class II	2014-08-07
K141787	Sagittilt	Orfit Industries NV	IYE	Class II	2014-08-07
K141782	Hi-Torque Versaturn Guide Wire	Abbott Vascular	DQX	Class II	2014-08-07
K141614	Magellan Robotic System	Hansen Medical, Inc.	DXX	Class II	2014-08-07
K141612	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	FRG	Class II	2014-08-07
K141423	Nasopore-Fd	Polyganics B.V.	LYA	Class I	2014-08-07
K141403	Litho Dk30	Quanta System Inc.	GEX	Class II	2014-08-07
K141371	Sonicision Cordless Ultrasonic Dissector	Covidien, Formerly Valleylab, A Division of Tyco H	LFL	Unclassified	2014-08-07
K141365	Otrieva Tapered Ovum Aspiration Needle Single Lumen	William A. Cook Australia Pty, Ltd.	MQE	Class II	2014-08-07
K141283	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2014-08-07
K141241	Matrixrib Endo Thoracoscopic Rib Plating System	Synthes (USA) Products LLC	HRS	Class II	2014-08-07
K141236	Nc Emerge Ptca Dilatation Catheter (Monorail), Nc Emerge Ptca Dilatation Catheter (Over-the-Wire)	Boston Scientific Corporation	LOX	Class II	2014-08-07
K141209	Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres	Celonova Biosciences, Inc.	KRD	Class II	2014-08-07
K141005	Z-Link Cervical	Zavation	OVE	Class II	2014-08-07
K140956	Lcd Monitor	NordicNeuroLab AS	LNH	Class II	2014-08-07
K140812	Mi-750 Procedural/minor Surgical Light	Medical Illumination International, Inc	FSY	Class II	2014-08-07
K140620	Sporview Plus Bi Test Pack	Crosstex International, Inc.	FRC	Class II	2014-08-07
K140563	Lateral Vbr System	Nu Vasive, Incorporated	MQP	Class II	2014-08-07