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 658 of 3529

510(k) clearances, page 658 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160790	Acclarix LX8 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYN	Class II	2016-04-04
K160464	Opticage(R) Expandable Interbody Fusion Device	Interventional Spine, Inc.	MAX	Class II	2016-04-04
K160325	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2016-04-04
K160283	S45 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2016-04-04
K160124	LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System	Spinevision Inc.	MNI	Class II	2016-04-04
K153481	0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe	Becton Dickinson & Co	NGT	Class II	2016-04-04
K152479	HG Pro Nitrile Powder Free Examination Gloves	Healthy Glove Co., Ltd.	LZA	Class I	2016-04-04
K152228	Hydroven 12, Hydroven 12 Garments	Huntleigh Healthcare Ltd.	JOW	Class II	2016-04-04
K151967	Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter	Merit Medical Systems, Inc.	MSD	Class II	2016-04-04
K151650	SMARTez elastomeric infusion pump	Epic Medical Pte., Ltd.	MEB	Class II	2016-04-04
K160459	FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch	BioFire Diagnostics, LLC	PCH	Class II	2016-04-01
K160320	Premier	Shandong Weigao Orthopaedic Device Co.,Ltd	MNI	Class II	2016-04-01
K160318	PlasmaFlow	Manamed LLC	JOW	Class II	2016-04-01
K160258	X5 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2016-04-01
K153583	BioVision Plus	Faxitron Bioptics, LLC	MWP	Class II	2016-04-01
K153562	Powder Free Blue Nitrile Examination Glove	Vietglove Corporation	LZA	Class I	2016-04-01
K153486	Affirm Prone Biopsy System	Hologic, Inc.	IZH	Class II	2016-04-01
K153263	Aquilion Lightning, TSX-035A/4 and /5, V7.0	Toshibamedical Systems Corporation	JAK	Class II	2016-04-01
K153249	Pulpdent Solo Flowable Composite with MCP	Pulpdent Corporation	EBF	Class II	2016-04-01
K152881	Sentinel Cardiology Information Management System	GE Healthcare	DQK	Class II	2016-04-01
K151156	Fiagon Navigation System	Fiagon GmbH	HAW	Class II	2016-04-01
K143690	Ekso™ (version 1.1) and Ekso GT™ (version 1.2)	Ekso Bionics	PHL	Class II	2016-04-01
K143548	TRUE METRIX GO Self Monitoring Blood Glucose System	Trividia Health, Inc.	NBW	Class II	2016-04-01
K160861	Proxis Ureteral Access Sheath	C.R. Bard Inc	FED	Class II	2016-03-31
K160267	PRECICE Trauma Nail System	Ellipse Technologies, Incorporated	HSB	Class II	2016-03-31
K153779	Abutment for Bridges	Altatec GmbH	NHA	Class II	2016-03-31
K153772	Corin TriFit TS Hip	Corin USA	MEH	Class II	2016-03-31
K153708	Halyard Black-Orange Powder-Free Nitrile Exam Glove	Halyard Health	LZA	Class I	2016-03-31
K153687	Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL	Liofilchem S.r.l.	JWY	Class II	2016-03-31
K153547	ECHELON Oval V 5.1 MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2016-03-31
K153495	Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System	Ldr Spine USA	MAX	Class II	2016-03-31
K153465	AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)	Assure Tech. (Hangzhou) Co., Ltd.	DKZ	Class II	2016-03-31
K153447	MAGNETOM Spectra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2016-03-31
K153348	Jazz Lock	Implanet	OWI	Class II	2016-03-31
K153291	Sicat Optisleep	Sicat GmbH & Co. KG	LRK	Class II	2016-03-31
K153146	Infrared Ear Thermometer	Sejoy Electronics & Instruments Co., Ltd.	FLL	Class II	2016-03-31
K152969	Enhance Allograft Wedge Instrument Tray	ConMed Corporation	KCT	Class II	2016-03-31
K152480	Revitive Medic; Revitive MV; Revitive LV	Actegy Ltd.	NGX	Class II	2016-03-31
K152428	SensiCare PI Surgical Gloves	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2016-03-31
K152258	T3 Software	Etiometry Inc.	PLB	Class II	2016-03-31
K152021	Pure Tilt	Proactive Comfort, LLC	IOR	Class I	2016-03-31
K151997	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)	Hartalega NGC Sdn Bhd	LZA	Class I	2016-03-31
K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	Stryker Corp.	HRX	Class II	2016-03-31
K151832	Novatech Talcair	Novatech S.A.	GCJ	Class II	2016-03-31
K151612	NewTom VGi evo	Qr S.r.l.	OAS	Class II	2016-03-31
K160637	Rotatable Snares	Boston Scientific Corporation	FDI	Class II	2016-03-30
K160620	Visaris Vision® (Vision C, Vision U. Vision V, Vision X)	Visaris d.o.o. Belgrade	KPR	Class II	2016-03-30
K153389	Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)	In Light Wellness Systems, Inc.	ILY	Class II	2016-03-30
K153281	BrightMatter Guide with Surface Trace Registration	Synaptive Medical Inc	HAW	Class II	2016-03-30
K153160	AVIVO Mobile Patient Management (MPM) System	Medtronic, Inc.	MHX	Class II	2016-03-30