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 1435 of 3531

510(k) clearances, page 1435 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032300	Accolade-J Hip Stem Series	Howmedica Osteonics Corp	MEH	Class II	2003-10-09
K032196	Nbd Disposable RF Cannulae	New Business Development, LLC	GXI	Class II	2003-10-09
K032175	Desens-Ionomer	Milton Hodosh, M.D.	EMA	Class II	2003-10-09
K032138	Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter	Medtronic, Inc.	KLA	Class II	2003-10-09
K031265	Shiraz-Java Spinal Fixation System	Spine Next SA	MNH	Class II	2003-10-09
K031125	Cynosure Smart File Nd:yag Lasers	Cynosure, LLC	GEX	Class II	2003-10-09
K031061	Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components	Zimmer GmbH	MBH	Class II	2003-10-09
K030472	Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System	Ethicon Endo-Surgery Inc	KNW	Class II	2003-10-09
K024361	Em Probe, Em Pad	Em Probe, Inc.	ILY	Class II	2003-10-09
K024105	Velopex Aquacut Fluid Abrasion Unit	Velopex International, Inc.	KOJ	Class II	2003-10-09
K032960	Wide 2Mp Tft Lcd Monitor System If 1902A	Wide Corporation	LLZ	Class II	2003-10-08
K032795	Ge 0.7T Signa Openspeed with Excite Mr System	GE Healthcare	LNH	Class II	2003-10-08
K032772	Modification to Watchchild Obstetrical Patient Data Management System (Also Referred to as) the Watchchild System	Hill-Rom Manufacturing, Inc.	HGM	Class II	2003-10-08
K032770	Endotine Forehead Device	Coapt Systems, Inc.	HWC	Class II	2003-10-08
K032605	Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling	Meta Biomed Co., Ltd.	KIF	Class II	2003-10-08
K032437	Chemstrip 5 Ob, Chemstrip 7 and Chemstrip 10 Md Test Strips	Roche Diagnostics GmbH	JIL	Class II	2003-10-08
K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	MEB	Class II	2003-10-07
K032603	Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling	Meta Biomed Co., Ltd.	KIF	Class II	2003-10-07
K032411	Js Vascular Guide Wire Vise/torque Device	Js Vascular, Inc.	DQX	Class II	2003-10-07
K032323	Brothers Powdered Synthetic Vinyl Patient Examination Gloves, Yellow	Long First (Xiamen) Plastics Co., Ltd.	LYZ	Class I	2003-10-07
K032195	Dentaurum Glastec Dental Orthodontic Cement	Dentaurum Inc.	DYH	Class II	2003-10-07
K032180	Nuvasive Cement Restrictor	NuVasive Inc	JDK	Class II	2003-10-07
K032098	Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models Ar-5024B, Ar-5025B	Arthrex GmbH	HWC	Class II	2003-10-07
K031909	Betec Retractable Safety Syringe (5Ml)	Betec Medical Science Co., Ltd.	MEG	Class II	2003-10-07
K031873	I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set	I-Stat Corp.	JJX	Class I	2003-10-07
K031564	Css	Medical Scientific, Inc.	GEI	Class II	2003-10-07
K031413	Vigormist Compressor Nebulizer	Vega Technologies Inc.	BTI	Class II	2003-10-07
K031263	3M Liquid Bandage, Model 120-Lb	3M Company	KMF	Class I	2003-10-07
K030886	Nico with Mars, Model 7300	Respironics Novametrix, LLC.	CCK	Class II	2003-10-07
K023366	Datex-Ohmeda 7900 Ventilator Enhancements	GE Healthcare	CBK	Class II	2003-10-07
K032918	C.t.m. Mobility Scooter, Model Hs-235	C.T.M. Homecare Product, Inc.	INI	Class II	2003-10-06
K032817	External Drainage Set	Integra Neurosciences Implants S.A.	JXG	Class II	2003-10-06
K032751	Modification to Renew Lead Extension	Abbott Medical	GZB	Class II	2003-10-06
K032721	Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	GEI	Class II	2003-10-06
K032687	Ace Nancy Nail	Depuy Orthopaedics Inc.	HTY	Class II	2003-10-06
K032668	Disposable Powder Free Vinyl Synthetic Exam Gloves	Kingswell International, Inc.	LYZ	Class I	2003-10-06
K032655	Bd Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-10-06
K032634	Normed Compression Bone Screw System	Noviace Corporation	JDS	Class II	2003-10-06
K032574	Dimension Drug Calibrator II, Model Dc49c	Siemens Healthcare Diagnostics Inc.	DKB	Class II	2003-10-06
K032458	Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott	Abbott Medical	JIT	Class II	2003-10-06
K032441	F-10 Folding Power Chair	Wheelchair & Scooter Express	ITI	Class II	2003-10-06
K032407	Optiband Lc	Sybron Dental Specialties, Inc.	DYH	Class II	2003-10-06
K031386	Lalan Gloves (Pvt) Ltd Glove, Patient Examination, Latex	Lalan Gloves (Pvt), Ltd.	LYY	Class I	2003-10-06
K030757	Coach 777-4	Wheelchair & Scooter Express	INI	Class II	2003-10-06
K030756	Coach 777-3	Wheelchair & Scooter Express	INI	Class II	2003-10-06
K030081	Csf400 and Csf600	Inmed Ltda.	JXG	Class II	2003-10-06
K024072	Duckworth & Kent Ltd Lens Delivery System	Duckworth & Kent, Ltd.	MSS	Class I	2003-10-06
K032776	Vacurect Vacuum Constriction Device	Vacurect Manufacturing (Pty), Ltd.	LKY	Class II	2003-10-03
K032736	Heart 2006	Aerotel Medical Systems (1998), Ltd.	DXH	Class II	2003-10-03
K032725	Mosfet Autosense Wireless	Thomson & Nielsen Electronics, Ltd.	IYE	Class II	2003-10-03