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 2026-10-29, 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 793 of 3530

510(k) clearances, page 793 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140015	Cardiosolutions Dexterity Steerable Introducer	Cardiosolutions, Inc.	DYB	Class II	2014-02-05
K133867	Surflo Winged Infusion Set with Needle Protection (Surshield)	Terumo Europe N.V.	FPA	Class II	2014-02-05
K133666	Rt016 Inspiratory Filter	Fisher & Paykel Healthcare, Inc.	CAH	Class II	2014-02-05
K133601	Advia Centaur Intact Parathyroid Hormone (Ipth) Assay	Siemens Healthcare Diagnostics Inc.	CEW	Class II	2014-02-05
K133550	Validate Ferritin Calibration Verification/ Linearity Test Kit	Maine Standards Co.	JJX	Class I	2014-02-05
K132613	Sonilase Light Therapy Device	Biorenew Labs, LLC	OHS	Class II	2014-02-05
K133794	4.5Mm Healix Advance Br Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5Mm Healix Advance Br Anchor, with 2 or 3	DePuy Mitek, Inc.	MAI	Class II	2014-02-04
K133757	Gfs II Standard, Gfs II Large, Gfs Mimi	Parcus Medical, L.L.C.	MBI	Class II	2014-02-04
K133737	Zimmer(r) Persona the Personalized Kee System 14X +30Mm Tapered Stem Extension	Zimmer GmbH	JWH	Class II	2014-02-04
K132886	Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System	Smith & Nephew, Inc.	HRS	Class II	2014-02-04
K132602	Streamline Express	NxStage Medical Inc	KDI	Class II	2014-02-04
K132383	Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter	Gyrus ACMI, Inc.	LJE	Unclassified	2014-02-04
K132140	Duteck(michealth)digital Clinical Thermometer	Duteck Industrial Co., Ltd.	FLL	Class II	2014-02-04
K131653	Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls	Lin-Zhi International Inc	DKZ	Class II	2014-02-04
K130582	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Heze City Green Food Co., Ltd.	LYZ	Class I	2014-02-04
K130320	Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw	Medtronic, Inc.	DQA	Class II	2014-02-04
K133557	Juliet Ll Lateral Lumbar Cage	Spineart SA	MAX	Class II	2014-02-03
K133151	Sarns High Flow Aortic Arch Cannula	Terumo Cardiovascular Systems Corporation	DWF	Class II	2014-02-03
K132767	Medline Sharps Container	MEDLINE INDUSTRIES, LP - Northfield	MMK	Class II	2014-02-03
K131292	Deroyal Spine Spacer System	DeRoyal Industries, Inc.	MAX	Class II	2014-02-03
K131249	On-Q Painbuster, on-Q C-Bloc, Homepump Eclipse, Homepump C-Series	Halyard Health	MEB	Class II	2014-02-03
K123475	Shoocin Introducer Kit	Lepu Medical Technology (Beijing) Co., Ltd	DYB	Class II	2014-02-03
K140012	Sorin Flextherm	LivaNova Deutschland GmbH	DWC	Class II	2014-01-31
K134002	6Mp Color Lcd Monitor, Radiforce Rx650	Eizo Corporation	LLZ	Class II	2014-01-31
K133967	Interbody Cage System	Aurora Spine, Inc.	MAX	Class II	2014-01-31
K133855	Breezy Elegance	Sunrise Medical, Inc.	IOR	Class I	2014-01-31
K133796	Nexsite Hd, Hemodialysis Catheter for Long Term Use (32Cm), Nexsite Hd, Hemodialysis Catheter for Long Term Use (36Cm),	Marvao Medical Devices Ltd.	MSD	Class II	2014-01-31
K133730	Co Pilot/regius Unitea	Konica Minolta, Inc.	LLZ	Class II	2014-01-31
K133655	Radiance V2	Gmv Soluciones Globales Internet S.A.U.	MUJ	Class II	2014-01-31
K133343	Wondfo Rapid Strep a Test	Guangzhou Wondfo Biotech Co., Ltd.	GTY	Class I	2014-01-31
K133240	Varian Multileaf Collimator	Varian Medical Systems, Inc.	IYE	Class II	2014-01-31
K133038	Sensititre Yeastone Susceptibility Plates	Trek Diagnostic Systems, Ltd.	NGZ	Class II	2014-01-31
K133034	Logiq F Series	GE Healthcare	IYN	Class II	2014-01-31
K132807	Monitoring Station, Connex(r) Central Station (Cs)	Welch Allyn Inc	MWI	Class II	2014-01-31
K132792	Ecoship Disposable Sharps Container, Ecoship Disposable Sharps Container	Daniels Sharpsmart, Inc.	MMK	Class II	2014-01-31
K132356	Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40St	Scican Ltd.	EGS	Class I	2014-01-31
K132221	Powder-Free Vinyl Patient Examination Gloves	Shandong Haoyu Medical Products Co., Ltd.	LYZ	Class I	2014-01-31
K132135	Lina Gold Loop Hc	LiNA Medical Inc	KNF	Class II	2014-01-31
K132070	Vita Suprinity(r)	Vita Zahnfabrik H.Rauter GmbH & Co.	EIH	Class II	2014-01-31
K131907	Raypex 6	Dentsply International, Inc.	LQY	Unclassified	2014-01-31
K131696	Vesalius	Telea Electronic Engineering S.r.l.	GEI	Class II	2014-01-31
K131592	Enlightn Renal Guide Catheter	Abbott Medical	DQY	Class II	2014-01-31
K131571	Avd Right Radial Drape	Advanced Vascular Dynamics	KKX	Class II	2014-01-31
K131555	Medsource IV Safety Catheter	Medsource International, LLC	FOZ	Class II	2014-01-31
K130003	Xiralite Flourescence Imaging System X4	Mivenion GmbH	IZI	Class II	2014-01-31
K140019	Arthrex Biosuture	Arthrex GmbH	GAT	Class II	2014-01-30
K133681	Crux Snare Filter Retrieval Set	Volcano Corporation	MMX	Class II	2014-01-30
K133275	Mini Tightrope	Arthrex GmbH	HTN	Class II	2014-01-30
K133229	Titanium Suture Anchor	Mtp Solutions, LLC	MBI	Class II	2014-01-30
K133192	Mectalif Tipeek	Medacta International SA	MAX	Class II	2014-01-30