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 763 of 3530

510(k) clearances, page 763 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141284	Caspian Spinal System	K2M, Inc	KWP	Class II	2014-07-23
K141256	Okamoto Studded Condom	Okamoto U.S.A., Inc.	HIS	Class II	2014-07-23
K141208	Dynamic Neuroscreening Device	Prosenex	LQW	Class I	2014-07-23
K141049	Ifuse Implant System	SI-Bone, Inc.	OUR	Class II	2014-07-23
K140775	Turbo-Elite Atherectomy Catheters, Turbo Tandem System	Spectranetics Corp.	MCW	Class II	2014-07-23
K140578	Arthroscopic Energy System	ConMed Corporation	GEI	Class II	2014-07-23
K140552	Cadwell Spike and Seizure Detector	Cadwell	OMB	Class II	2014-07-23
K133759	Intellijoint Hip	Intellijoint Surgical Inc.	OLO	Class II	2014-07-23
K133535	Infx-8000V, V5.30	Toshibamedical Systems Corporation	OWB	Class II	2014-07-23
K133306	Sis Hernia Graft	Cook Biotech, Inc.	FTM	Class II	2014-07-23
K132820	Vilex Ultima External Fixation System with Ha Coated Pins and Wires	Vilex, Inc.	JDW	Class II	2014-07-23
K141678	Emboshield Nav6 Embolic Protection System	Abbott Vascular	NTE	Class II	2014-07-22
K141677	Variax Elbow Plating System	Stryker Trauma GmbH	HRS	Class II	2014-07-22
K141663	Eeva Dish (with 12 Microwells)	Auxogyn, Inc.	MQK	Class II	2014-07-22
K141652	Cedars-Sinai Cardiac Suite Nuclear Medicine Software	Cedars Sinai Medical Center	KPS	Class II	2014-07-22
K141583	Shaser Skin Beauty Intense Pulsed Light System Family	Shaser, Inc.	ONF	Class II	2014-07-22
K141154	Oartrac System	Radiadyne	NZT	Class II	2014-07-22
K140876	View Plating System,reduce Fracture Plating System,bone Screw	Icon Orthopedic Concepts, LLC dba Edge Orthopaedic	HRS	Class II	2014-07-22
K140864	Veloxtm Interbody Fusion System	CG MedTech Co., Ltd.	ODP	Class II	2014-07-22
K140487	Vis-U-All Low Temperature Sterilization Pouch/tubing	STERIS Corporation	FRG	Class II	2014-07-22
K140456	Bio-Connekt Wound Matrix	MLM Biologics	KGN	Unclassified	2014-07-22
K140273	Equalizer Occlusion Balloon Catheter	Boston Scientific Corporation	MJN	Class II	2014-07-22
K133370	Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve Ce	Signature Orthopaedics Pty Limited	LPH	Class II	2014-07-22
K133364	Picosure Workstation	Cynosure, LLC	GEX	Class II	2014-07-22
K131721	Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1	Comed Medical Systems Co., Ltd.	LNS	Class II	2014-07-22
K130097	Medmate Transfer Adapter Am5500 & Am5500-Ns	American Medical Manufacturing, Inc./ Advanced Med	FMI	Class II	2014-07-22
K141034	Azul Personal Lubricant	Church & Dwight Co., Inc.	NUC	Class II	2014-07-21
K140915	Excia Total Hip System	Aesculap Inc	LZO	Class II	2014-07-21
K140879	Biosure Healicoil Pk Interference Screw	Smith & Nephew, Inc.	MBI	Class II	2014-07-21
K140726	Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for Standard Gastroscopes - Box 5, Captiv	Boston Scientific Corporation	FDI	Class II	2014-07-21
K134031	Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter	Boston Scientific Corporation	LOX	Class II	2014-07-21
K133419	Babymeg Biomagnetometer System	Tristan Technologies, Inc.	OLY	Class II	2014-07-21
K141654	The Belmont Rapid Infuser	Belmont Medical Technologies	FRN	Class II	2014-07-18
K141641	Zonare Zs3 Diagnostic Ultrasound System	Zonare Medical Systems, Inc.	IYN	Class II	2014-07-18
K141639	Voluson S6, Voluson S8	GE Healthcare	IYN	Class II	2014-07-18
K141625	Polysyn Surgical Suture	Surgical Specialties Corp	GAM	Class II	2014-07-18
K141577	Arthrex Pip Dart	Arthrex GmbH	HTY	Class II	2014-07-18
K141430	Variax Distal Radius Plating System	Stryker Leibinger GmbH & Co. KG	HRS	Class II	2014-07-18
K141280	Ilens (Ocufilcon D) Daily Soft Contact Lens	Seinoh Optical Co., Ltd	LPL	Class II	2014-07-18
K141265	Elitech Clinical Systems Envoy 500 Ck Reagent Kit	ELITechGroup Inc	JHW	Class II	2014-07-18
K141219	Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits	Biomet Manufacturing Corp	HTN	Class II	2014-07-18
K141118	Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter	Medtronic, Inc.	LIT	Class II	2014-07-18
K141100	Optilite C1 Inactivator Kit	The Binding Site Group Ltd.	DBA	Class II	2014-07-18
K140897	Syngo.mr Neurology, Syngo.mmr General	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-07-18
K140845	Levo Tinnitus Masking Software Device	Otoharmonics Corp	KLW	Class II	2014-07-18
K140518	Geistlich Mucograft: 15 X 20 Mm, 20 X 30 Mm, 8 Mm Diameter	Geistlich Pharma AG	NPL	Class II	2014-07-18
K140200	E-Shield Multi-Paired Subdermal Needle Electrodes	Neuroinvent, Inc.	GXZ	Class II	2014-07-18
K140082	Aequalis(tm) Ascent(tm) Flex Shoulder System	Tornier S.A.S.	PHX	Class II	2014-07-18
K140005	Alma Diode Tabletop Laser	Alma Lasers Ltd.	GEX	Class II	2014-07-18
K133699	Powder Free Green, Blue and Brown Polychloroprene Examination Gloves	Pt. Smartglove Indonesia	LZA	Class I	2014-07-18