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 757 of 3530

510(k) clearances, page 757 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141294	U by Kotex Security Unscented Menstrual Tampons	Kimberly-Clark Corporation	HEB	Class II	2014-08-25
K140550	Orthohub External Fixator Software	Orthohub, Inc.	OSN	Class II	2014-08-25
K133769	3B Resmart Bpap 25A, Bmc Resmart Bpap 25A	3B Medical Inc	BZD	Class II	2014-08-25
K133322	Steritec Smart-Read Biological Test Pack with Instant Readout Integrator	Steritec Products Mfg. Co., Inc.	FRC	Class II	2014-08-25
K142017	X-Porte Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2014-08-22
K142002	Breast Speeder Cx, Grid Holder Cx	Quality Electrodynamics	MOS	Class II	2014-08-22
K141642	Vapro Intermittent Catheter	Hollister Incorporated	GBM	Class II	2014-08-22
K141597	Mustang Balloon Dialation Catheter	Boston Scientific Corporation	FGE	Class II	2014-08-22
K141509	Isola and Expedium Growing Spine Systems	Medos SARL	PGM	Class II	2014-08-22
K141480	Cvi42	Circle Cardiovascular Imaging Inc	LLZ	Class II	2014-08-22
K141446	Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing Screener without Barcode Scanner,	Natus Medical Incorporated	GWJ	Class II	2014-08-22
K141372	Mercury Spinal System	Spinal Elements, Inc	NKB	Class II	2014-08-22
K141288	Voyant Electrosurgical Generator, Voyant 5Mm Laparoscopic Sealer-Divider Device	Applied Medical Resources Corp	GEI	Class II	2014-08-22
K141083	Microlife Wrist Watch Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2014-08-22
K141065	Constellation Vision System	Alcon Laboratories	HQE	Class II	2014-08-22
K140946	Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite	Novabone Products, LLC	MQV	Class II	2014-08-22
K140945	Compactcath Intermittent Urinary Catheter	Compactcath, Inc	EZD	Class II	2014-08-22
K140944	1.8 Mm Phoenix Atherectomy Catheter, 2.2 Mm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip	Atheromed, Inc.	MCW	Class II	2014-08-22
K140689	Iknee Distal Femoral Cutting Guide	Evergreen Orthopedic Research Lab	OLO	Class II	2014-08-22
K140210	Rightest Blood Glucose Monitoring System ( Gm720, Rightest Professional Bgms Gm720	Bionime Corporation	NBW	Class II	2014-08-22
K140149	Epx-4440Hd Digital Video Processor	FUJIFILM Healthcare Americas Corporation	PEA	Class II	2014-08-22
K140086	Personal Kinetigraph (Pkg) System	GKC Manufacturing Pty Ltd	GYD	Class II	2014-08-22
K133925	Vyntus/ Sentrysuite Product Line	Carefusion Germany 234 GmbH	BZC	Class II	2014-08-22
K133921	Preceptis Tympanostomy Tube Inserter	Preceptis Medical, Inc	ETD	Class II	2014-08-22
K133592	Neodent Implant System, Titamax Ti Ex Acqua and Ti Drive Acqua, Titamax Smart Ex Acqua and Drive Smart Acqua, Titamax Cm	Neodent USA, Inc.	DZE	Class II	2014-08-22
K132772	Lubrigyn Cream	Uniderm Farmaceutici SRL	NUC	Class II	2014-08-22
DEN120017	Medtronic DUET External Drainage and Monitoring System	Medtronic Neurosurgery	PCB	Class II	2014-08-22
K142148	Orthohelix Staple System	TORNIER Inc.	JDR	Class II	2014-08-21
K142121	Valor Hindfoot Fusion Nail System	Wrightmedicaltechnologyinc	HRS	Class II	2014-08-21
K142006	Symbia 6.0	Siemens Medical Solutions USA, Inc.	KPS	Class II	2014-08-21
K141930	Osseoflex Sb, 10G/4ml, Osseoflex Sb, 10G/2ml	Osseon, LLC	NDN	Class II	2014-08-21
K141585	Smith & Nephew Disposable Fin Punch	Smith & Nephew, Inc.	JWH	Class II	2014-08-21
K141567	Igrow - II Hair Growth System, Igrow Hair Growth System	Apira Science, Inc.	OAP	Class II	2014-08-21
K141521	Mustang Balloon Dilatation Catheter/charger Pta Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2014-08-21
K141508	Romeo 2 Pad Posterior Axial Device	Spineart SA	PEK	Class II	2014-08-21
K141357	Barrx Flex Rfa Energy Generator	Covidien Iic	GEI	Class II	2014-08-21
K141264	Tensyn Band, Tensyn Fracture Plates	Dallen Medical, Inc.	HTN	Class II	2014-08-21
K141215	Surgiseal Twist Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2014-08-21
K141127	Medline Anti-Embolism Stocking	MEDLINE INDUSTRIES, LP - Northfield	DWL	Class II	2014-08-21
K141004	Intraosseous Fixation System	TORNIER Inc.	HTY	Class II	2014-08-21
K140681	Belter Infra-Red Ear Thermometer	Shenzhen Belter Health Measurement and Analysis TE	FLL	Class II	2014-08-21
K140600	Sb Anchor	OSSTEM Implant Co., Ltd.	NHA	Class II	2014-08-21
K140028	Galt Vti Low Insertion Valve Tearaway Introducer	Galt Medical Corp	DYB	Class II	2014-08-21
K133706	Zl Microdent Natural Lock Implant System	Zl Microdent-Attachment GmbH & Co. KG	DZE	Class II	2014-08-21
K133638	Geko	Firstkind Ltd	IPF	Class II	2014-08-21
K133532	Alaris System with Guardrails Suite Mx	CareFusion 303, Inc	FRN	Class II	2014-08-21
K132326	Ionsil Gel	Virchow Biotech Pvt. Ltd.	FRO	Unclassified	2014-08-21
K141788	Obsidian Milling Blocks	Prismatik Dentalcraft, Inc.	EIH	Class II	2014-08-20
K141308	Nutra Light Red	Nutra Luxe MD, LLC	OHS	Class II	2014-08-20
K140965	Multipiezo Pro, Multipiezo	Mectron S.p.A.	ELC	Class II	2014-08-20