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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 627 of 3529

510(k) clearances, page 627 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K151139	EasyMap MAP Catheter	MedFact Engineering GmbH	DRF	Class II	2016-10-18
K162614	Infinix, INFX-8000V, V6.35	Toshibamedical Systems Corporation	OWB	Class II	2016-10-17
K161960	bk2300	BK Medical ApS	IYN	Class II	2016-10-17
K161604	OSSTEM Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2016-10-17
K162579	VascuCel	Admedus Regen Pty, Ltd.	DXZ	Class II	2016-10-14
K162487	BSD3543 Digital Flat Panel X-ray Detector	Bontech Co., Ltd	MQB	Class II	2016-10-14
K162290	MyLabSix CrystaLine	Esaote S.p.A.	IYN	Class II	2016-10-14
K162011	MedDream	Softneta UAB	LLZ	Class II	2016-10-14
K161981	Olive Plus	Ama Network, Inc.	GEX	Class II	2016-10-14
K161912	ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip	Asahi Intecc Co., Ltd.	MOF	Class II	2016-10-14
K161886	Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device	Guangdong Transtek Medical Electronics Co.,Ltd	DXN	Class II	2016-10-14
K161882	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	LFL	Unclassified	2016-10-14
K161714	Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	DIS	Class II	2016-10-14
K161687	D-10 Hemoglobin A1c Program	Bio-Rad Laboratories Inc.	PDJ	Class II	2016-10-14
K161569	Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	LPH	Class II	2016-10-14
K161546	R2P SlenGuide	Ashitaka Factory of Terumo Corp.	DQY	Class II	2016-10-14
K161361	HawkOne Directional Atherectomy System	Medtronic, Inc.	MCW	Class II	2016-10-14
K161184	iNSitu Total Hip System	Theken Companies LLC	LPH	Class II	2016-10-14
K160782	BracePaste Adhesive	American Orthodontics	DYH	Class II	2016-10-14
K160371	NovaPACS	Novarad Corp.	LLZ	Class II	2016-10-14
K160279	ANYVIEW-500R Fluoroscopic Mobile X-Ray System	ECOTRON Co., Ltd.	OWB	Class II	2016-10-14
K160268	Fingertip Pulse Oximeter MD300CG11/MD300CG51	Beijing Choice Electronic Technology Co., Ltd.	DQA	Class II	2016-10-14
K153577	FREND Testosterone Test System	Nanoentek USA, Inc.	CDZ	Class I	2016-10-14
K153521	IH Implant System	Sewonmedix, Inc.	DZE	Class II	2016-10-14
K162596	Air Optix Colors	Alcon Laboratories	LPL	Class II	2016-10-13
K162571	Bioflux Software	Biotricity	DSH	Class II	2016-10-13
K161964	ADVIA Centaur HAV IgM Assay	Siemens Healthcare Diagnostics Inc.	LOL	Class II	2016-10-13
K161842	Overwatch Spine System	Spinal Elements, Inc	NKB	Class II	2016-10-13
K161537	OTC TENS Device, Model PTS-IV	Counter Scientific Development (Gz), Ltd.	NUH	Class II	2016-10-13
K161410	VT·One, VT·One 60days	Carilex Medical, Inc.	OMP	Class II	2016-10-13
K160562	Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs	Hartalega Snd. Bhd.	LZA	Class I	2016-10-13
K160076	XCage™ Interbody Fusion System	Ouroboros Medical	MAX	Class II	2016-10-13
K153685	Sunmed Haemostatic Valves	Sunny Medical Device (Shenzhen) Co., Ltd.	DQX	Class II	2016-10-13
K162550	Medtronic Model 5392 External Pulse Generator (EPG)	Medtronic, Inc.	DTE	Class II	2016-10-12
K162424	Ulna Plating System	Zimmer GmbH	HRS	Class II	2016-10-12
K162404	Express SD Biliary Monorail Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2016-10-12
K162341	Stryker OrthoMap Precision Knee system	Stryker Leibinger GmbH & Co. KG	OLO	Class II	2016-10-12
K161931	Toricolors (hioxifilcon D) Soft Contact Lenses	Polydev, Ltd.	LPL	Class II	2016-10-12
K161815	FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band	Genesee BioMedical, Inc.	KRH	Class II	2016-10-12
K161152	Navien Intracranial Support Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	DQY	Class II	2016-10-12
K161110	ClearPetra Suction-Evacuation Sheath	Well Lead Medical Co. Ltd	FED	Class II	2016-10-12
K160103	Spetzler Malis Dual Illuminating Bipolar Forceps	Synergetics Inc	GEI	Class II	2016-10-12
K153550	FTRD System Set	Ovesco Endoscopy AG	PKL	Class II	2016-10-12
K162599	IcePearl 2.1 CX L, IceForce 2.1 CX L	Galil Medical Ltd.	GEH	Class II	2016-10-11
K161449	HammerTech Fixation System	Fusion Orthopedics, LLC	HWC	Class II	2016-10-11
K162664	Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2016-10-07
K161677	Straumann Sterile Healing Solution	Straumann USA, LLC	NHA	Class II	2016-10-07
K161642	CAVUX™ Cervical Cage	Providence Medical Technology, Inc.	ODP	Class II	2016-10-07
K161496	Turbo-Flo PICC Sets	Cook Incorporated	LJS	Class II	2016-10-07
K161038	PK Morcellator	Gyrus ACMI, Inc.	GEI	Class II	2016-10-07