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 765 of 3530

510(k) clearances, page 765 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140830	Exprt Revision Knee	Encore Medical, LP	JWH	Class II	2014-07-11
K140459	Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System	ConMed Corporation	GEI	Class II	2014-07-11
K140451	Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series Digital (LED Option)	Keeler Ltd.	HJO	Class II	2014-07-11
K140316	Examination Gloves	HL Rubber Industries Sdn Bhd	LZA	Class I	2014-07-11
K140186	The Stork OTC	Rinovum Subsidiary 2, LLC	OBB	Class II	2014-07-11
K133676	Abx Pentra Micro Alb Control L/h	Horiba Abx SAS	JJY	Class I	2014-07-11
K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona Fs-01 Laser Handpiece	Fotona D.D.	GEX	Class II	2014-07-11
K131513	Scenar (Scelap, Enisar, Ipens) Cutaneous Electrode Family	Ritm Okb Zao	GZJ	Class II	2014-07-11
K131094	Vimove	Dorsa VI Pty., Ltd.	IKN	Class II	2014-07-11
K141027	3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar II Implant, Dorsal Columella Imp	Implantech Associates Inc	FWP	Class II	2014-07-10
K140976	Enaden Flow	Km Corporation	EBF	Class II	2014-07-10
K140765	Range/mesa/denali Spinal System	K2M, Inc	NKB	Class II	2014-07-10
K140658	Thermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive Electrodes	ConMed Corporation	GEI	Class II	2014-07-10
K140626	Meluna Classic/sport Menstrual Cup	meluna	HHE	Class II	2014-07-10
K140101	Abmedica Reusable Laparoscopic Hand Instruments and Trocars	AB Medica SAS	GCJ	Class II	2014-07-10
K133819	Veradius	Philips Medical Systems Nederland B.V.	OWB	Class II	2014-07-10
K133443	Marathon No Sting Liquid Skin Protectant	Advanced Medical Solutions (Plymouth), Ltd.	KMF	Class I	2014-07-10
K132919	Gantry Beam Line	Ion Beam Applications S.A.	LHN	Class II	2014-07-10
K131692	Blossom Saline Delivery Assist Device	Marz Medical, Inc.	LCJ	Unclassified	2014-07-10
K141444	Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-07-09
K141417	Charlotte (Tm) Mtp Bone Fusion Plate System Hex Screw	Wrightmedicaltechnologyinc	HRS	Class II	2014-07-09
K141245	Etex Mixing and Delivery System	Etex Corp.	FMF	Class II	2014-07-09
K140917	Introducer, Model Adelante Magnum	Oscor Inc.	DYB	Class II	2014-07-09
K140531	Biofoam Bone Wedge	Wrightmedicaltechnologyinc	HRS	Class II	2014-07-09
K140513	Merit Safety Introducer Needle	Merit Medical Systems, Inc.	DYB	Class II	2014-07-09
K140417	Divergence Mini-Plate Anterior Cervical Fusion System	Medtronic Sofamor Danek	KWQ	Class II	2014-07-09
K140409	Flents Plastic Eye Wash Cup	Apothecary Products, LLC	LXQ	Unclassified	2014-07-09
K134005	Mirocam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2014-07-09
K141618	Arrow Vps Stylet Plus and Cg+ Arrow Picc Powered by Arrow Vps Stylet Plus	Arrow International, Inc (Subsidiary of Teleflex I	OBJ	Class II	2014-07-08
K141478	Arthrex Fracture Plates and Screws	Arthrex GmbH	HRS	Class II	2014-07-08
K141273	Welldoc Diabetesmanager System and Diabetesmanager- Rx Syste	Welldoc	MRZ	Class II	2014-07-08
K141228	Aos 6.5Mm Captured, Fully Threaded Cancellous Screw	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2014-07-08
K141151	CT Midline	Medcomp ( Medical Components)	LJS	Class II	2014-07-08
K141117	Ez-Io Intraosseous Infusion System	Teleflex Medical	FMI	Class II	2014-07-08
K141102	Hospira Mednet Medication Management Suite	Abbott Medical	FRN	Class II	2014-07-08
K140816	Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)	Better Care Plastic Technology Co., Ltd.	LZA	Class I	2014-07-08
K140643	Gryphon Br Anchor W/proknot Technology,gryphon Peek Anchor W/ Proknot Technology	DePuy Mitek, Inc.	MAI	Class II	2014-07-08
K140144	Benda Wedge	Centrix, Inc.	EJB	Class I	2014-07-08
K133811	Restoris Porous Partial Knee System	Mako Surgical Corp.	NJD	Class II	2014-07-08
K132761	Wireless Thermometer	Raiing Medical Company	FLL	Class II	2014-07-08
K141432	Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2014-07-07
K141051	Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement Hu	Arrow International LLC (subsidiary of Teleflex Incorporated)	MSD	Class II	2014-07-07
K140785	Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2014-07-07
K140324	Rigidloop Adjustable Cortical Implant: Standard, Long and Xl	DePuy Mitek, Inc.	MBI	Class II	2014-07-07
K133784	Vista-S Device, Associated Instrumentation	Zimmer Trabecular Metal Technology, Inc.	ODP	Class II	2014-07-07
K133648	Syngo, CT Dual Energy	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-07-07
K133299	Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly	Fresenius Medical Care, North America - Renal Ther	KDI	Class II	2014-07-07
K132778	Grab 'N Go Plus, Grab 'N Go Digital	Praxair Healthcare Services	ECX	Class I	2014-07-07
K132214	Abutment Rp, Abutment Wp, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator Abutment, Solid Abutment, Retentive	Hager & Meisinger GmbH	NHA	Class II	2014-07-07
K131601	Dell U3014 with Qubyx Perfectlum Bundle	Qubyx Limited	PGY	Class II	2014-07-07