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 749 of 3530

510(k) clearances, page 749 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142280	Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)	Healgen Scientific LLC	DJG	Class II	2014-10-16
K142184	Dx-D Imaging Package	AGFA Healthcare Corp.	MQB	Class II	2014-10-16
K141801	Hawkone Directional Atherectomy System	Medtronic, Inc.	MCW	Class II	2014-10-16
K141753	Aquarius Nasal Feeding Tube	Degania Silicone, Inc.	PIF	Class II	2014-10-16
K141584	Ultraflex Tracheobronchial Covered Stent System	Boston Scientific Corporation	JCT	Class II	2014-10-16
K140598	Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc	Dima Italia SRL	NHJ	Class II	2014-10-16
K140543	Preludeease Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	DYB	Class II	2014-10-16
K140023	Elevation	Pdg Product Design Group Inc	IOR	Class I	2014-10-16
K133677	Syngo CT Single Source Dual Energy	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-10-16
K133488	Piezomed	W & H DentalWerk Buermoos GmbH	DZI	Class II	2014-10-16
K133390	Ndx Dorsal Appliance	Institute for Quality Resource Management	LRK	Class II	2014-10-16
K142346	Urine/CSF Albumin, Urine/CSF Albumin Calibrator	Beckman Coulter Ireland Inc	DCF	Class II	2014-10-15
K142193	Cogent Med-Lif Xl	Cogent Spine, LLC	MAX	Class II	2014-10-15
K142095	Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System	Renovis Surgical Technologies, LLC	OVD	Class II	2014-10-15
K141954	Xcel 455 Slit Lamp	Reichert, Inc.	HJO	Class II	2014-10-15
K141865	Dana	Anthrotronix, Inc.	LQD	Unclassified	2014-10-15
K141776	Stratafix Symmetric Pds Plus Knotless Tissue Control Devices	Ethicon, Inc	NEW	Class II	2014-10-15
K140470	Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber	Oberon GmbH Fiber Technologies	GEX	Class II	2014-10-15
K140025	Aquamax (Etafilcon a) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2014-10-15
K134009	UV Biotek Single Panel, UV Biotek Multi-Directional	Medtek Lighting	FTC	Class II	2014-10-15
K131987	Multipulse Hoplus	Asclepion Laser Technologies GmbH	GEX	Class II	2014-10-15
K142616	PICC Maximal Barrier Nursing Kit	Boston Scientific Corporation	LJS	Class II	2014-10-14
K142277	Juliet Po	Spineart SA	MAX	Class II	2014-10-14
DEN130044	Inflow Intraurethral Valve-Pump	Vesiflo, Inc.	PIH	Class II	2014-10-14
K142628	Acuson SC2000 Diagnostic Ultrasound System	Siemens Medi Cal Solutions, Inc.	IYN	Class II	2014-10-10
K142614	AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits	Boston Scientific Corporation	GEX	Class II	2014-10-10
K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	GE Medical Systems, Israel Ltd.	IYN	Class II	2014-10-10
K142160	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	IYN	Class II	2014-10-10
K142037	Quantra	Hologic, Inc.	LLZ	Class II	2014-10-10
K142033	Verigene Enteric Pathogen Nucleic Acid Test (Ep)	Nanospere,Inc.	PCH	Class II	2014-10-10
K142014	Sofia Distal Access Catheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2014-10-10
K141869	Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit	Hemedex Incorporated	GWM	Class II	2014-10-10
K141399	Freedom Spinal Cord Stimulator (Scs) System	Stimwave Technologies Incorporated	GZB	Class II	2014-10-10
K141106	Frontier Devices Fusio Screw Fuze System	Folsom Metal Products, Inc. dba Frontier Devices	OUR	Class II	2014-10-10
K140938	Ostom-I Alert	11 Health and Technologies, LLC	EXB	Class I	2014-10-10
K140619	Meca Xpressfish	Advandx, Inc.	MYI	Class II	2014-10-10
K140463	Integra External Fixation System	Ascension Orthopedic	KTT	Class II	2014-10-10
K140120	Epic 10	Biolase, Inc.	GEX	Class II	2014-10-10
K133441	Onestep CPR II Multi-Function Electrode	ZOLL Medical Corporation	MKJ	Class III	2014-10-10
K131925	Hs Nota	H.S. Hospital Services S.p.A.	FCG	Class II	2014-10-10
K142396	Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests	Chemtron Biotech, Inc.	DJG	Class II	2014-10-09
K141972	Klassic Hd Acetabular Insert with E-Link Poly	Total Joint Orthopedics, Inc.	OQG	Class II	2014-10-09
K141931	Lyra Adenovirus Assay	Ortho-Clinical Diagnostics, Inc.	OCC	Class II	2014-10-09
K141927	Lyra Parainfluenza Virus Assay	Ortho-Clinical Diagnostics, Inc.	OOU	Class II	2014-10-09
K141791	Biomet Fusion System	Highridge Medical, LLC	OVD	Class II	2014-10-09
K141659	Prism Zirconia, St-98	A & D Dental Innovations	EIH	Class II	2014-10-09
K141416	Blood Pressure Monitor	Shenzhen Pump Medical System Co., Ltd.	DXN	Class II	2014-10-09
K140805	Itclamp 50	Innovative Trauma Care Inc	DXC	Class II	2014-10-09
K140319	Coroent Ti-C System	NuVasive Inc	MAX	Class II	2014-10-09
K133990	Ieva Rehabilitative Positional Device	Remendium Labs, LLC	HIR	Class II	2014-10-09