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 742 of 3530

510(k) clearances, page 742 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141952	Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced	Ethicon Endo-Surgery Inc	GDW	Class II	2014-11-24
K141940	Conchasmart Column	Teleflex Medical	BTT	Class II	2014-11-24
K141939	Telefelx Isis Hvt Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet	Teleflexmedical, Inc.	BTR	Class II	2014-11-24
K141682	Tvc Imaging System, Tvc Insight Catheter	Nipro Vascular Innovations Americas, Inc.	OGZ	Class II	2014-11-24
K140716	Opticage Expandable Interbody Fusion Device	Interventional Spine, Inc.	MAX	Class II	2014-11-24
K140573	Woundclot Hemostatic Gauze	Core Scientific, Ltd.	QSY	Unclassified	2014-11-24
K140566	Spsmedical Vh2o2 Indicator Strips, Indicator Labels, Indicator Tape	Crosstex International, Inc.	JOJ	Class II	2014-11-24
K133766	Humicare D900	Gruendler GmbH	BTT	Class II	2014-11-24
K142045	Xpert Flu/rsv Xc Assay	Cepheid	OCC	Class II	2014-11-22
K143261	2.3MP Color LCD Monitor, RadiForce MX242W	Eizo Corporation	PGY	Class II	2014-11-21
K143106	VEGA Knee System	Aesculap Inc	JWH	Class II	2014-11-21
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity	Aalto Scientific Ltd.	JJX	Class I	2014-11-21
K142868	5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin	Purple Surgical International Limited	GEI	Class II	2014-11-21
K142681	ZEUS (ZIO ECG Utilization Service) System	iRhythm Technologies, Inc.	DQK	Class II	2014-11-21
K142668	Lesion-Loc Iodine I-125 Seed/Needle	Intramedical Imaging LLC.	KXK	Class II	2014-11-21
K142525	PK Lap Loop	Olympus Winter & Ibe GmbH	HIN	Class II	2014-11-21
K142434	Artiste Solution, Sys_vc10c, Phase 2 Update with the Syngo Rt Therapist & Rt Oncologist Workspaces, V4.3.1_mr1	Siemens Medical Solutions USA, Inc.	IYE	Class II	2014-11-21
K142197	Ultrasound System Sonimage Hs1, Linear Probe L18-4, Convex Probe C5-2	Konica Minolta, Inc.	IYN	Class II	2014-11-21
K142183	Glidesheath Slender	Terumo Medical Corp.	DYB	Class II	2014-11-21
K141872	Sudoscan	Impeto Medical	GZO	Class II	2014-11-21
K141377	Bioball Delta Ceramic Heads, Multicup Pe Inlay Standard	Merete GmbH	LZO	Class II	2014-11-21
K134006	Disposable Laparoscopic Electrode, Disposable Laparoscopic Electrode	Modern Medical Equipment Manufacturing Ltd.	GEI	Class II	2014-11-21
K133997	Lg Smarthealth	LG Electronics Inc.	DRG	Class II	2014-11-21
K133674	Philips Iqon Spectral CT	Philips Healthcare (Cleveland)	JAK	Class II	2014-11-21
K133362	Sgs Dental Implant	S.G.S. International Ltd	DZE	Class II	2014-11-21
K133348	Stim Probe	Spes Medica S.P.A	ETN	Class II	2014-11-21
K143234	MaxZero Administration Sets	Care Fusion	FPA	Class II	2014-11-20
K143038	Gel-Block 10X embolization pledgets	Vascular Solutions LLC	KRD	Class II	2014-11-20
K143027	Xario 200, V3.0	Toshibamedical Systems Corporation	IYN	Class II	2014-11-20
K142978	Audit MicroControls Linearity LQ Special Diabetes	Aalto Scientific Ltd.	JJY	Class I	2014-11-20
K142585	PhaLinx Hammertoe System	Wrightmedicaltechnologyinc	HWC	Class II	2014-11-20
K142520	Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software	Smith & Nephew, Inc.	KTT	Class II	2014-11-20
K142303	NeumoFilt Ergo/Neumo Filt BiteOn	Medical Respiratory Devices S.L.	BZG	Class II	2014-11-20
K142100	Aixplorer	Supersonic Imagine	IYN	Class II	2014-11-20
K142062	Spiral Flow Peripheral Vascular Graft	Vascular Flow Technologies Ltd	DSY	Class II	2014-11-20
K142023	Luna Interbody System	Benvenue Medical, Inc.	MAX	Class II	2014-11-20
K142012	Farrell Valve System with Equilibrium Technology and Enfit Enteral Connectors	Halyard Health	PIF	Class II	2014-11-20
K141896	Coroent System	Nu Vasive, Incorporated	MAX	Class II	2014-11-20
K143047	Arthrex iBalance Patella Implant, Dome	Arthrex GmbH	JWH	Class II	2014-11-19
K143046	Xario 100, V3.0	Toshibamedical Systems Corporation	IYN	Class II	2014-11-19
K142999	EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable	ArthroCare Corporation	GEI	Class II	2014-11-19
K142600	VIAL-MATE Adaptor	Baxter Healthcare Corporation	LHI	Class II	2014-11-19
K142510	UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens	Synergeyes, Inc.	HQD	Class II	2014-11-19
K142499	Reline System	Nu Vasive, Incorporated	NKB	Class II	2014-11-19
K142399	DualCap IV Pole Strips(Disinfectant Caps for Male Luers)	Catheter Connections, Inc.	QBP	Class II	2014-11-19
K142251	AVS AS PEEK Spacer	Stryker Corp.	ODP	Class II	2014-11-19
K142185	Expedium Verse Spine System	DePuy Spine, Inc.	NKB	Class II	2014-11-19
K141977	Magnetom Aera with Software Syngo Mr E11a, Magnetom Skyra with Software Syngo Mr E11a, Magnetom Skyra with 24 RF Channel	Siemens Medical Solutions USA, Inc.	LNH	Class II	2014-11-19
K141811	Mortara Monitoring Waveform Viewer	Mortara Instrument, Inc.	MHX	Class II	2014-11-19
K141794	Endo-Maryland Dissector	Ovesco Endoscopy AG	KGE	Class II	2014-11-19