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 579 of 3529

510(k) clearances, page 579 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162633	Custom Bars	Implant Direct Sybron Manufacturing LLC	NHA	Class II	2017-07-24
K162950	Vitek Ms	bioMerieux, Inc.	PEX	Class II	2017-07-22
K171855	External Moisturizing Gel	Combe Incorporated	NUC	Class II	2017-07-21
K171753	BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16	Leica Biosystems Newcastle Ltd.	MXZ	Class II	2017-07-21
K171597	Vantage Elan 1.5T, V4.0	Toshibamedical Systems Corporation	LNH	Class II	2017-07-21
K171441	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit	Luminex Corporation	OZN	Class II	2017-07-21
K171003	3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader	3M Company	FRC	Class II	2017-07-21
K170832	Ultimax-i, DREX-UI80 V1.60	Toshibamedical Systems Corporation	OWB	Class II	2017-07-21
K170532	True Form Reshapable Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2017-07-21
K170223	Progreat	Ashitaka Factory of Terumo Corp.	DQO	Class II	2017-07-21
K163232	Vitrea View	Canon Medical Informatics, Inc.	LLZ	Class II	2017-07-21
K162778	Portable Slit Lamp Microscope	Suzhou Kangjie Medical, Inc.	HJO	Class II	2017-07-21
K161527	Teco Creatinine Enzymatic Reagent Kit	Teco Diagnostics	JFY	Class II	2017-07-21
K152257	Fujifilm Duodenoscope Model ED-530XT	FUJIFILM Healthcare Americas Corporation	FDT	Class II	2017-07-21
K171701	GelPOINT Path Transanal Access Platform	Applied Medical Resources Corp	FER	Class II	2017-07-20
K171616	Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color	Shandong Xingyu Gloves Co., Ltd	LZA	Class I	2017-07-20
K171439	EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System	Medos International SARL	KWQ	Class II	2017-07-20
K171425	Concorde Lift	Medos International SARL	MAX	Class II	2017-07-20
K170326	dynaMX Intramedullary Implant	Arthrex GmbH	HTY	Class II	2017-07-20
K170219	Microlife Digital Infrared Ear Thermometer	Microlife Intellectual Property GmbH	FLL	Class II	2017-07-20
K163589	SIGN IM Nail	SIGN Fracture Care International	HSB	Class II	2017-07-20
K163025	DORA Disposable A.V. Fistula Needle Sets	Bain Medical Equipment(guangzhou) Co., Ltd.	FIE	Class II	2017-07-20
K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors	Abbott Medical	PWH	Class II	2017-07-20
K171957	MaxZero Extension Sets with Needless Connector	CareFusion 303, Inc	FPA	Class II	2017-07-19
K171838	TiLock2 Spinal System	Genesys Spine	NKB	Class II	2017-07-19
K171812	Nio Color 2MP (MDNC-2123)	Barco N.V.	PGY	Class II	2017-07-19
K171290	Vela RX PTA Balloon Dilatation Catheter	Curatia Medical Co.	LIT	Class II	2017-07-19
K171093	Sterile Nitrile Patient Examination Gloves, Powderfree	Sanrea Healthcare Products Pvt Ltd	LZA	Class I	2017-07-19
K170978	Embrace Neonatal MRI System	Aspect Imaging Ltd	LNH	Class II	2017-07-19
K170852	POD Packing Coil	Penumbra Inc.	HCG	Class II	2017-07-19
K170775	Mini Stick ENVI Non-Vascular Introducer Kit	Boston Scientific Corporation	DYB	Class II	2017-07-19
K170675	Graftgun Universal Graft Delivery System	Surgentec LLC	FMF	Class II	2017-07-19
K170379	Disposable Standard Clamp	Standard Bariatrics	GCJ	Class II	2017-07-19
K170182	Cardiovit Ft-1	Schiller, AG	DPS	Class II	2017-07-19
K163687	Olinda Exm	Hermes Medical Solutions AB	IYX	Class I	2017-07-19
K163388	XPress BCD Breast Compression Device	Xpress BCD LLC	POY	Class II	2017-07-19
K163159	Dario Blood Glucose Monitoring System	Labstyle Innovations, Ltd.	NBW	Class II	2017-07-19
DEN170022	QuantX	Quantitative Insights, Inc.	POK	Class II	2017-07-19
K171844	Inspire ICE aka Inspire ICE Clear Brackets	Ormco Corp.	NJM	Class II	2017-07-18
K171824	Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYO	Class II	2017-07-18
K171807	ES2 Neuromonitoring Accessory Instruments	Stryker Corp.	PDQ	Class II	2017-07-18
K171544	Arterys Viewer	Arterys Inc.	LLZ	Class II	2017-07-18
K171333	20G x 5/8 Pro-Lock CT Safety Infusion Set	Medcomp (dba Medical Components, Inc.)	PTI	Class II	2017-07-18
K171149	Altrix Temperature Management Wraps	Stryker Medical	DWJ	Class II	2017-07-18
K171021	JO Agapé Personal Lubricant	United Consortium	NUC	Class II	2017-07-18
K170786	Faxitron Bioptics Speciemen Radiography System	Faxitron Bioptics, LLC	MWP	Class II	2017-07-18
K170729	Examion X-AQS	Examion, Inc.	LLZ	Class II	2017-07-18
K170100	CreoDent Solidex Customized Abutment and Screw	Creodent Prosthetics Ltd	NHA	Class II	2017-07-18
K163714	Ossix Bone	Datum Dental, Ltd.	NPM	Class II	2017-07-18
K163064	Demi Ultra	Sybron Dental Specialties, Inc.	EBZ	Class II	2017-07-18