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 770 of 3530

510(k) clearances, page 770 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133553	Kalare	Toshiba America Medical Systems, In.C	JAA	Class II	2014-06-13
K133098	Senyint Pacs	Dalian Senyint Digital Medical System Co., Ltd.	LLZ	Class II	2014-06-13
K132978	Impact Dx Factor V Leiden and Factor II Genotyping Test	Sequenom, Inc.	PHJ	Class II	2014-06-13
K132816	Oncentra Brachy	Nucletron BV	MUJ	Class II	2014-06-13
K132524	CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application	Philips North America LLC	JAK	Class II	2014-06-13
K132003	Winx Sleep Therapy System	Apnicure, Inc.	OZR	Class II	2014-06-13
K131080	Physiolaser Olympic, Single Probes Cw, Cluster Probes Cw, Light Needle, Photonic Satellite	Reimers and Janssen GmbH	ILY	Class II	2014-06-13
K122807	Dental Implant System	Hager & Meisinger GmbH	DZE	Class II	2014-06-13
K141381	Duradiagnost	Philips Healthcare (Suzhou) Co., Ltd.	KPR	Class II	2014-06-12
K141360	Tripleplay Pro	Wildcat Medical, Inc.	JOW	Class II	2014-06-12
K141306	Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site	Teva Medical Ltd., Migada Plant	FPA	Class II	2014-06-12
K141233	Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface	Medtronic, Inc.	DTN	Class II	2014-06-12
K140730	Vial2bag Direct Connect	West Pharma. Services IL, Ltd.	LHI	Class II	2014-06-12
K140695	Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire	Medtronic, Inc.	DQX	Class II	2014-06-12
K140361	Meta-C Cervical Plate	Medacta International SA	KWQ	Class II	2014-06-12
K140322	White Vinyl Exam Gloves Powder Free	Shandong Dawei Medical Products Co., Ltd.	LYZ	Class I	2014-06-12
K140314	Wartie Wart Remover	Yonmedical BV	GEH	Class II	2014-06-12
K140242	Feiyue	Feiyue Glove Co., Ltd.	LYZ	Class I	2014-06-12
K140240	Zhaofeng	Zhaofeng Glove Co., Ltd.	LYZ	Class I	2014-06-12
K140239	Jiawang	Jiawang Glove Co., Ltd.	LYZ	Class I	2014-06-12
K133280	Terumo Surflo i.v. Catheter	Terumo (Philippines) Corporation	FOZ	Class II	2014-06-12
K132375	Genistrong Single-Use Specimen Retrieval Bag	Genicon, Inc.	GCJ	Class II	2014-06-12
K141250	Flexible Video-Uretero-Renoscope System	Karl Storz Endoscopy-America, Inc.	FGB	Class II	2014-06-11
K140996	Mammi	General Equipment for Medical Imaging (Oncovision	KPS	Class II	2014-06-11
K140955	Mta2.1 Material	Avalon Biomed, Inc.	KIF	Class II	2014-06-11
K140854	Intra-Operative Ultrasound Transducer	Hitachi Aloka Medical, Ltd.	ITX	Class II	2014-06-11
K140662	Flex Endoscopic Instruments	Design Standards Corp.	GCJ	Class II	2014-06-11
K140651	Celesteion, Pca-9000A/2	Toshibamedical Systems Corporation	KPS	Class II	2014-06-11
K140425	Contrast Modulation System	Osprey Medical, Inc.	DXT	Class II	2014-06-11
K134022	Base It	Spident Co., Ltd.	EJK	Class II	2014-06-11
K133403	Firesoft-Sihy. Ic Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens	Firestone Optics, Inc.	LPL	Class II	2014-06-11
K133132	Optical Biometer Al-Scan	Nidek Co., Ltd.	HJO	Class II	2014-06-11
K132954	Jo Premium Personal Lubricant	United Consortium	NUC	Class II	2014-06-11
K131858	Digital Electrocardiograph	Guangdong Biolight Meditech Co., Ltd	DPS	Class II	2014-06-11
K141259	Gryphon Br Anchor with Permacord, Gryphon Br Ds Anchor with Permacord,gryphon Peek Anchor with Permacord, Gryphon Peek	DePuy Mitek, Inc.	MAI	Class II	2014-06-10
K141019	Amicus Separator System/ Amicus Seperator System;refurbished	Fenwal Inc	LKN	Unclassified	2014-06-10
K140985	Sensititre Haemophilus/streptococcus Pneumoniae(hp) Susceptibility Plates	Thermo Fisher Scientific Oy	JWY	Class II	2014-06-10
K140975	Mastersl Femoral Stem	Lima Corporate S.p.A.	LZO	Class II	2014-06-10
K140967	Freedom Inguinal Hernia Repair Implant-25Mm/40mm/40mm with Extended Disk	Insightra Medical Inc	FTL	Class II	2014-06-10
K140675	Emerge External Fixation System	Emerge Medical	KTT	Class II	2014-06-10
K140642	Pcd 737A	MEGO AFEK AC Ltd.	JOW	Class II	2014-06-10
K140521	Topaz Ez Microdebrider Coblation Wand with Integrated Finger Switch	ArthroCare Corporation	GEI	Class II	2014-06-10
K140374	Mastergraft Putty	Medtronic Sofamor Danek USA Inc	LYC	Class II	2014-06-10
K140331	Orthalign Plus System	OrthAlign, Inc.	OLO	Class II	2014-06-10
K140138	Heartnavigator Release 2.0	Philips Medical Systems Nederland B.V.	OWB	Class II	2014-06-10
K134021	Estemp Implant, Estemp Clear	Spident Co., Ltd.	EMA	Class II	2014-06-10
K133770	A.i.m. Knotless Meniscal Repair Device	Anchor Innovation Medical (A.I.M.)	GAT	Class II	2014-06-10
K133494	Chesapeake Spinal System	K2M, Inc	OVD	Class II	2014-06-10
K133297	Quadrostarprogreen, Quadrostarproyellow	Asclepion Laser Technologies GmbH	GEX	Class II	2014-06-10
K132920	Spirox Inex Device	Spirox, Inc.	NHB	Class II	2014-06-10