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 2026-11-02, 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 1046 of 3531

510(k) clearances, page 1046 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091457	Nexstim Eximia Navigated Brain Stimulation System	Nexstim Inc.	GWF	Class II	2009-12-08
K091051	Bollard Miniplate Skeletal Anchorage System	Tita-Link	DZE	Class II	2009-12-08
K090686	Sic Brevetti S.r.l. Device for Sternal Synthesis	Sic Brevetti S.r.l.	JDQ	Class II	2009-12-08
K083372	Arrowbone-a, Arrowbone-B	Brainbase Corporation	LYC	Class II	2009-12-08
K083371	Navigator Pro with Aep Software (Biomark, Enog, Champ)	Bio-Logic Systems Corp.	GWF	Class II	2009-12-08
K082683	Sd Check Gold	Standard Diagnostics, Inc.	NBW	Class II	2009-12-08
K093522	Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2009-12-07
K093166	Wittmann Patch	Aperta, LLC	FTL	Class II	2009-12-07
K093051	Hylatopic Plus Emollient Foam	Collegium Pharmaceutical Incorporated	FRO	Unclassified	2009-12-07
K092951	Starlight Pro and Siliverlight Dental Curing Lights	Mectron S.p.A.	EBZ	Class II	2009-12-07
K092793	Modification To:kneehab Xp Conductive Garment, Model 411	Bio-Medical Research, Ltd.	GXY	Class II	2009-12-07
K092782	Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35c, Connector Luer Lock, Model C35,	Carmel Pharma AB.	LHI	Class II	2009-12-07
K092534	Alatus Vaginal Balloon Packing System	Radiadyne	JAQ	Class II	2009-12-07
K091875	E-Pulse	Medevice, Inc.	BWK	Unclassified	2009-12-07
K091746	Waterlase Md, Model 7100102	Biolase MG LLC	GEX	Class II	2009-12-07
K091198	Liquid Filled Ring Teether, Model 03807, Liquid Filled Ring Teether, Models 1962005, 1962011, Liquid Filled Teething	Allied Hill Enterprises, Ltd.	KKO	Class II	2009-12-07
K082965	Ds-a Blood Glucose Monitoring System	Alliance International Corp. Ltd.	CGA	Class II	2009-12-07
K093600	Omnistim Continence+ Pelvic Floor Stimulation System	Accelerated Care Plus Corp.	KPI	Class II	2009-12-04
K093570	Powder Free Vinyl Patient Examination Gloves, Light Yellow Color	Jiangsu Jaysun Glove Co., Ltd.	LYZ	Class I	2009-12-04
K093528	Fully Automatic Electronic Blood Pressure Monitor Model Kd-5963, Kd-7963	Andon Health Co., Ltd	DXN	Class II	2009-12-04
K093458	Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298	Siemens Healthcare Diagnostics Inc.	JFY	Class II	2009-12-04
K093455	Carto 3 Version 1.05 Ep Navigation System and Accessories	Biosense Webster Inc	DQK	Class II	2009-12-04
K093233	D3 Fastpoint L-Dfa Rsv/mvp Identification Kit	Ortho-Clinical Diagnostics, Inc.	OMG	Class II	2009-12-04
K093199	3M Comply Bowie- Dick Type Lead Free Test Pack	3M Company	JOJ	Class II	2009-12-04
K093171	Viamo Ssa-640A Version 1.2	Toshiba America Medical Systems, In.C	IYN	Class II	2009-12-04
K093165	Arthrocare System 15000 Controller, Arthrowands	ArthroCare Corporation	GEI	Class II	2009-12-04
K092956	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shandong Aobo Medical Co, Ltd.	LYZ	Class I	2009-12-04
K092936	Amigo Escort 7.5, Model 760001 Phs	Amigo Mobility Intl., Inc.	ITI	Class II	2009-12-04
K092620	Md300c318 Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2009-12-04
K092603	Cobas Integra Glucose Hk Gen 3 Assay	Roche Diagnostics GmbH	CFR	Class II	2009-12-04
K092514	Upperarm Digital Blood Pressure Monitor, Model: Mb-300 Series	Hangzhou Hua'an Medical & Health Instruments Co.	DXN	Class II	2009-12-04
K092482	Tissu Trans Filtron, Models 3-Tt-Filtron 2000-500	Summit Medical, LLC	MUU	Class II	2009-12-04
K091838	Obp Self Sealing Endoscopic Seal with Luer Lock	OBP Medical Corporation	HIH	Class II	2009-12-04
K091672	Disposable Grounding Pad Series and Electrode Series	Shuyou Electric Medical Science Co., Ltd.	GEI	Class II	2009-12-04
K091582	Gtx Guidewire, Models Tbd-Gtx 1, 3,6,9,12, 15	Medtronic, Inc.	DQX	Class II	2009-12-04
K091507	Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18	Rayner Intraocular Lenses Limited	MSS	Class I	2009-12-04
K091352	Soundstar 3D Diagnostic Catheter, Model M-5723-05	Biosense Webster Inc	OBJ	Class II	2009-12-04
K091302	Integra Mozaik and Os Moldable Morsels	Integra LifeSciences Corporation	MQV	Class II	2009-12-04
K090889	Emsi Garment Electrodes	Emsi	GXY	Class II	2009-12-04
K090628	Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080	Medrad, Inc.	NBW	Class II	2009-12-04
K093639	Slit Lamp, Models Hs-5000, Hs-5500 and Hs-7500	Huvitz Co., Ltd.	HJO	Class II	2009-12-03
K093591	Stimpod Model Nms-400 Nerve Stimulator	Xavant Technology (Pty) Ltd	BXN	Class II	2009-12-03
K093446	Vita Vmk Master	Vita Zahnfabrik H. Rauter GmbH & Co. KG.	EIH	Class II	2009-12-03
K093372	Sils Port Model Silspt15	Covidien Lp, Formerly Registered AS Tyco Healthcar	GCJ	Class II	2009-12-03
K092840	Instrumed Forceps Obstetrical/gynaecological	Instrumed International Inc dba Avalign German Specialty Instruments	HCZ	Class II	2009-12-03
K092820	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Fuhao Plastic Products Co., Ltd.	LYZ	Class I	2009-12-03
K092749	Mas and Mini-Trol Pth Control	Microgenics Corporation	JJX	Class I	2009-12-03
K092727	H100b Pulse Oximeter	Edan Instruments, Inc.	DQA	Class II	2009-12-03
K092660	Sirolaser Advance	Sirona Dental Systems GmbH	GEX	Class II	2009-12-03
K092605	Xia 4.5 Spinal System	Howmedica Osteonics Corp	NKB	Class II	2009-12-03