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 1505 of 3531

510(k) clearances, page 1505 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013805	Kowa Automated Tonometer Kt-500	Kowa Pharmaceuticals America, Inc.	HKX	Class II	2002-10-11
K012537	Reprocessed Imaging Catheters	Sterilmed Inc	OWQ	Class II	2002-10-11
K022797	Twinky Star	Voco GmbH	EBF	Class II	2002-10-10
K022316	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2002-10-10
K022306	Aart Silicone Tubing	Aesthetic and Reconstructive Technologies, Inc.	KGZ	Class I	2002-10-10
K023336	Oco Dental Implant (5.0Mm Diameter)	O Co., Inc.	DZE	Class II	2002-10-09
K023294	Bosworth Coraco-Clavicular Screw	Howmedica Osteonics Corp	HWC	Class II	2002-10-09
K023285	Diastat Anti Cyclic Citrullinated Peptide (Anti-Ccp) Elisa	Axis-Shield Diagnostics, Ltd.	NHX	Class II	2002-10-09
K023207	Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)	Toshiba America Medical Systems, In.C	LNH	Class II	2002-10-09
K023170	Nitrile Powder-Free Examination Gloves	Medtronic, Inc.	LZA	Class I	2002-10-09
K023134	Jet-X Tin Coated Half Pins	Smith & Nephew, Inc.	JDW	Class II	2002-10-09
K023102	Accolade Tmzf Plus Ha 127 Size 0 Hip Stem	Howmedica Osteonics Corp	MEH	Class II	2002-10-09
K022996	Vita in-Ceram Yz Cubes for Cerec	Vident	EIH	Class II	2002-10-09
K022826	Clear-It Anti-Fog, Model Ps003	Preservation Solutions Inc	OCT	Class II	2002-10-09
K022811	W-5	Ivoclar Vivadent, Inc.	EJT	Class II	2002-10-09
K022785	Epoch Xp Neurological Workstation; Epoch Xp Lite Neurological Workstation	Axon Systems, Inc.	GWQ	Class II	2002-10-09
K022748	Reprocssed Used Disposable Endoscopic Scissors and Graspers	Medical Device Services	HET	Class II	2002-10-09
K022743	Reprocessed Disposable Trocars	Medical Device Services	KAB	Class I	2002-10-09
K022666	Pdo (Polydioxanone) Monofilament Synthetic Absorbable Suture U.s.p.	Arc Medical Supplies (Beijing) Co, Ltd.	NEW	Class II	2002-10-09
K022665	Porous Hdpe Surgical Implants, to Be Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe	Hohenstein Enterprises, Inc.	KKY	Class II	2002-10-09
K022630	Modification to Focus	Instrumentarium Corp.	EHD	Class II	2002-10-09
K022581	Becton Dickinson Logic Blood Glucose Monitoring System	Becton Dickinson & Co	NBW	Class II	2002-10-09
K022580	Bacton Dickinson Latitude Blood Glucose Monitoring System	Becton Dickinson & Co	CGA	Class II	2002-10-09
K022489	Summit Medical Ltd Celltrans Postoperative Autotransfusion System, Models Abt4510, Abt4512 & Abt4514	Summit Medical, LLC	CAC	Class II	2002-10-09
K022472	Parathyroid Hormone Test System/nichols Advantage Quick-Intraoperative Bio-Intact Pth (1-84)	Nichols Institute Diagnostics	CEW	Class II	2002-10-09
K022342	Ez-Scope an, Ez-Scope Light	Anzai Medical Co, Ltd.	IYX	Class I	2002-10-09
K022321	Stockert V172-28 Venous Femoral Cannula	Stockert Instrumente GmbH	DWF	Class II	2002-10-09
K022238	Myocardial Lead Implant Tool, Model 10626	Medtronic, Inc.	DWS	Class I	2002-10-09
K021329	Rita System	Boston Scientific Corporation	GEI	Class II	2002-10-09
K021238	Frye Adjusting Instrument	Frye Health Systems	LXM	Unclassified	2002-10-09
K020948	Smith & Nephew Suretac - Expanded Indications II	Smith & Nephew, Inc.	JDR	Class II	2002-10-09
K023032	Liquitrol, Liquid Human Glycosyla,ted Hemoglobin (A1c) Control - Normal/abnormal	Bioresource Technology	GFS	Class II	2002-10-08
K022946	Lifesign Mi Myoglobin/troponin I Rapid Test	Princeton BioMeditech Corp.	MMI	Class II	2002-10-08
K022781	Midas Touch Purple Nitrile Examination Gloves-Polymer Coated, Powder Free	Industrial Clothings, Ltd.	LZA	Class I	2002-10-08
K022656	Sensititre 18-24 Hours Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2002-10-08
K022565	Telstar Biplane Digital Imaging System [Tis] Model 030-000915	Stereotaxis Inc	JAA	Class II	2002-10-08
K022495	Gettig Disposable Syringes	Gettig Pharmaceutical Instrument Co.	FMF	Class II	2002-10-08
K022441	Sterrad Sealsure Chemical Indicator Tape	Advanced Sterilization Products	JOJ	Class II	2002-10-08
K022322	Innova and Innova 2000 S	GE Healthcare	OWB	Class II	2002-10-08
K022307	Konrad, Model V.2.0	Mrc Systems GmbH	MUJ	Class II	2002-10-08
K022228	Family of Iris Medical Endoprobe Handpieces	Iridex Corporation	GEX	Class II	2002-10-08
K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models	Altus Medical, Inc.	GEX	Class II	2002-10-08
K021955	Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories	GE Healthcare	DQA	Class II	2002-10-08
K021716	Simplify Compact Resuscitator	Polymed (Xiamen) Plastic Industrial Co.,Ltd.	BTM	Class II	2002-10-08
K021333	Artemis	Ultralink, LLC	IYO	Class II	2002-10-08
K020670	Model 4310 Psarray2 EEG Electrode	Physiometrix, Inc.	GXY	Class II	2002-10-08
K020507	Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4	Olympus Winter & Ibe GmbH	GWG	Class II	2002-10-08
K020027	Focus Radiation Treatment Planning System	Elekta Limited	MUJ	Class II	2002-10-08
K022734	Pulpdent Calcium Hydroxide Preparation	Pulpdent Corporation	KIF	Class II	2002-10-07
K022373	Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens	Cantor & Nissel, Ltd.	NJH	Class I	2002-10-07