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 766 of 3530

510(k) clearances, page 766 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141134	Pod System	Penumbra Inc.	HCG	Class II	2014-07-03
K140962	Normed Vario Subtalar Screw	Normed Nedizin Technik GmbH	HWC	Class II	2014-07-03
K140902	E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series Patellae, Asymmetrical, 3-Peg	Zimmer GmbH	JWH	Class II	2014-07-03
K140869	Dcas I	Gp&p Co., Ltd.	LLZ	Class II	2014-07-03
K140652	Porous Coated Comprehensive Fracture Stems	Biomet Manufacturing Corp	PHX	Class II	2014-07-03
K140641	Vessix Guide Sheath 7F, 45 Cm, Rdc, Vessix Guide Sheath 7F, 45Cm, Lima	Boston Scientific Corporation	DYB	Class II	2014-07-03
K140333	Ascend	Neurometrix, Inc.	NUH	Class II	2014-07-03
K140241	Edwards Transfemoral Balloon Catheter	Edwards Lifesciences LLC	OZT	Class II	2014-07-03
K140141	Labonacheck Gluppy Blood Glucose Monitoring System	Ceragem Medisys, Inc.	NBW	Class II	2014-07-03
K133835	Arthrosurface Kissloc Knotless Suture System	Arthrosurface, Inc.	HTN	Class II	2014-07-03
K133689	Powder Free Polychloroprene Light Wieght Examinationgloves- Green,blue and Pink	PT. Medisafe Technologies	LZA	Class I	2014-07-03
K133528	H&h Emergency Cricothyrotomy Kit	H & H Medical Corporation	JOH	Class II	2014-07-03
K133114	Micropuncture Introducer Set	Cook Incorporated	DYB	Class II	2014-07-03
K132987	Cobra Fundus Camera	C.S.O. S.r.l.	HKI	Class II	2014-07-03
K132881	Z5c	Z-Systems AG	DZE	Class II	2014-07-03
K132543	Infant Incubator	Bistos co., Ltd.	FMZ	Class II	2014-07-03
K131923	Neurodyn Portable TENS Nfes, Neurodyn Portable TENS	Techlink International LLC	GZI	Class II	2014-07-03
K141620	Rs80a Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2014-07-02
K141556	Avreo Interworks System	Avreo, Inc.	LLZ	Class II	2014-07-02
K141499	X-Repairsl	Synthasome, Inc.	FTL	Class II	2014-07-02
K141485	Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle	Galil Medical Ltd.	GEH	Class II	2014-07-02
K141452	Leforte Neuro System Bone Plate and Screw	Jeil Medical Corporation	GWO	Class II	2014-07-02
K141392	Sphygmomanometer	Suzhou JJ Meter Co., Ltd.	DXQ	Class II	2014-07-02
K141369	Visiq Diagnostic Ultra Sound System	Philips North America LLC	IYN	Class II	2014-07-02
K140909	Mckesson Radiology	Change Healthcare Canada Company	LLZ	Class II	2014-07-02
K140849	Isoseed	Eckert & Ziegler Bebig GmbH	KXK	Class II	2014-07-02
K140685	Endo Vac Apical Negative Pressure Irigation System	Sybron Endo	NYL	Class I	2014-07-02
K140601	Flow-Nail	Flow-Fx, LLC	HSB	Class II	2014-07-02
K140596	Navio	Blue Belt Technologies, Inc.	OLO	Class II	2014-07-02
K140572	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH, Switzerland	DXN	Class II	2014-07-02
K140512	Ufill Bulk Fill Posterior Flowable Composite	Juno Dentistry LP	EBF	Class II	2014-07-02
K140351	Arrow Gpscath Balloon Dilatation Catheter	Hotspur Technologies,Inc Subsidiary of Teleflex ME	LIT	Class II	2014-07-02
K140260	Skyhawk Lateral Plate System	Orthofix SRL	KWQ	Class II	2014-07-02
K140162	Ap Expandable Xlif System	NuVasive Inc	MAX	Class II	2014-07-02
K140129	Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter	Abbott Medical	DQE	Class II	2014-07-02
K140121	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2014-07-02
K140055	Endoskeleton(r) Tl Interbody Fusion Device	Titan Spine, LLC	MAX	Class II	2014-07-02
K133861	Flash Ostial System Otw-7.0Mmx17mmx135cm, Flash Ostial System Otw-7.0Mmx17mmx80cm	Verge Medical Inc.	LIT	Class II	2014-07-02
K133110	Express Ld Biliary Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2014-07-02
K132384	U-Scope 8000 System with Hsc+emb Cannula	Endosec Corporation	HIH	Class II	2014-07-02
K141458	Simplexa Hsv 1&2 Direct/positive Control Pack	DiaSorin Molecular LLC	PGH	Class II	2014-07-01
K141406	Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls and Calibrators	Immunalysis Corporation	DJG	Class II	2014-07-01
K141234	Odissey Tissue Oximeter	Vioptix, Inc.	MUD	Class II	2014-07-01
K141148	Evolution Rl Controlled-Rotation Dilator Sheath Set, Evolution Shortie Rl Controlled-Rotation Dilator Sheath Set	Cook Vandergrift, Inc.	DRE	Class II	2014-07-01
K140843	Desara Blue Ov, Desara Blue Ss	Caldera Medical, Inc.	OTN	Class II	2014-07-01
K140411	Altera Spacer	Globus Medical, Inc.	MAX	Class II	2014-07-01
K140400	Es2 Neuromonitoring Accessory Instruments	Stryker Corp.	ETN	Class II	2014-07-01
K140379	Mega Big Boy Condom	Okamoto U.S.A., Inc.	HIS	Class II	2014-07-01
K133916	Carto 3 Ep Navigation System, Version 4.2	Biosense Webster Inc	DQK	Class II	2014-07-01
K133693	Digital Radiography Cxdi-401C Wireless	Canon, Inc.	MQB	Class II	2014-07-01