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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1212 of 3531

510(k) clearances, page 1212 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K070190	Gradia Direct X	GC America Inc.	EBF	Class II	2007-03-12
K070083	Quanta Lite H-Ttg/dgp Screen	Inova Diagnostics, Inc.	MST	Class II	2007-03-12
K063712	Avaulta Support System/avaulta Plus Biosynthetic Support System	C.R. Bard Inc	OTP	Class III	2007-03-12
K063647	Cystatin C Antiserum, Calibrator, Control and Control High	Thermo Electron Oy	NDY	Class II	2007-03-12
K061122	Night Guard	Alpine Oral Care, LLC	MQC	Unclassified	2007-03-12
K060764	Saturn 3 Laser System	Research Instruments Ltd	MRX	Class II	2007-03-12
K070528	Philips Essenta Dr	Philips Medical Systems DMC GmbH	MQB	Class II	2007-03-09
K070508	Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 Fr	C.R. Bard Inc	EZL	Class II	2007-03-09
K070477	Orison Embrace System	Orison Corporation	IYO	Class II	2007-03-09
K070378	Angiodynamics, Inc. 600Um Fiber and Venacure Procedure Kit	Boston Scientific Corporation	GEX	Class II	2007-03-09
K070370	21.3 Inch (54Cm) Monochrome Lcd Monitor Mdl2122a	Totoku Electric Co., Ltd.	LLZ	Class II	2007-03-09
K070369	Regenerx Ringloc + Modular Acetabular Shells	Zimmer GmbH	LPH	Class II	2007-03-09
K070275	Flexible Loop Electrosurgical Electrode	Rubicor Medical, Inc.	GEI	Class II	2007-03-09
K070226	Cardioct	Shina Systems Ltd.	LLZ	Class II	2007-03-09
K070123	Tca 5R / 5S	Dornier Medtech America, Inc.	OWB	Class II	2007-03-09
K063830	Remstar Aflex CPAP System	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2007-03-09
K063504	Econolith Em1000	Medispec, Ltd.	LNS	Class II	2007-03-09
K063464	Atlas Spine Vertebral Body Replacement	Atlas Spine, Inc.	MQP	Class II	2007-03-09
K062994	Lateralized Taperloc Microplasty Femoral Components	Biomet Manufacturing Corp	KWA	Class III	2007-03-09
K062909	Repeater Pump II Tube Sets	Baxa Corp.	FPA	Class II	2007-03-09
K062875	Endogastric Stomaphyx Device and Accessories	Endogastric Solutions, Inc.	OCW	Class II	2007-03-09
K062659	Kirwan Disposable Battery-Powered Cautery, Model 41-61Xx Series	Kirwan Surgical Products, LLC	HQP	Class II	2007-03-09
K061766	Expressway Intermittent Catheter	Percutaneous Systems, Incorporated	EZD	Class II	2007-03-09
K070344	Liv Breast Self Examination Aid	Liv International USA, Inc.	IZH	Class II	2007-03-08
K070192	Atrium Prolite Ultra S Mesh	Atrium Medical Corporation	FTL	Class II	2007-03-08
K070084	Montblanc Implantology Contra Angle Control	Est. Anthogyr	EFA	Class I	2007-03-08
K063552	Series II Constrained Acetabular Liners	Howmedica Osteonics Corp	KWZ	Class II	2007-03-08
K063550	System 12 Constrained Acetabular Liners	Howmedica Osteonics Corp	KWZ	Class II	2007-03-08
K063473	Synthes Orthodontic Bone Anchor System	Synthes (USA) Products LLC	OAT	Class II	2007-03-08
K063445	Pca Constrained Acetabular Liners	Howmedica Osteonics Corp	KWZ	Class II	2007-03-08
K063149	Orthodontic Taads (Temporary Anatomical Anchor Device System)	T.O.A.D.S., LLC	OAT	Class II	2007-03-08
K070305	Pre-Loaded Visicoil	Radiomed Corporation	IYE	Class II	2007-03-07
K070191	Alpha-Core Dc	Dental Technologies, Inc.	EBF	Class II	2007-03-07
K070179	Trokabone, Trokabone Sternal	Pajunk GmbH Medizintechnologie	FCG	Class II	2007-03-07
K070118	Otogram, Ca3350	Tympany, Inc.	EWO	Class II	2007-03-07
K070026	Powdered (Yellow) Vinyl Patient Examination Gloves	Shijiazhuang Lianhe Shunda Plastic Products Co., L	LYZ	Class I	2007-03-07
K063832	Synthes (USA) Elbow Hinge Fixator	Synthes (USA) Products LLC	LXT	Class II	2007-03-07
K063814	Bp-200 Plus	Schiller, AG	DXN	Class II	2007-03-07
K063694	Akreos Single Use Insertion Device, Model Ai-28	Bausch & Lomb Incorporated	KYB	Class I	2007-03-07
K063689	Bd Directigen Ez Flu A+b Test	Becton Dickinson & Co	PSZ	Class II	2007-03-07
K063648	Surgi-Wrap Mast Tendon Sheet	MAST Biosurgery USA, Inc	FTL	Class II	2007-03-07
K063646	Opti	Camsight Co., Inc.	EIA	Class I	2007-03-07
K063563	Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter	Cordis Europa, N.V.	LIT	Class II	2007-03-07
K063486	Bd Phoenix Automated Microbiology System Minocycline (1-32 Ug/ml) Gram Negative Id/ast or Ast Only	Becton Dickinson & Co	LON	Class II	2007-03-07
K063152	Claros Dental Laser System	Elexxion AG	GEX	Class II	2007-03-07
K063001	Slim Evolution Family of CO2 Lasers and Delivery Device Accessories	Lasering S.r.l.	GEX	Class II	2007-03-07
K062711	Ultra Low Profile Rongeur	Baxano, Inc.	HAE	Class II	2007-03-07
K070359	Depuy Asr Taper Sleeve Adapter	Depuy Orthopaedics Inc.	KWA	Class III	2007-03-06
K070162	Forcetriad Electrosurgical Generator; Ligasure Instruments	Valleylab,A Division of Tyco Healthcare Group LP	GEI	Class II	2007-03-06
K063726	Plc Suture Anchor	Smith & Nephew, Inc.	HRS	Class II	2007-03-06