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 1484 of 3531

510(k) clearances, page 1484 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023866	Powder Free Polymer Coated (Acrylic Based) Patient Examiniation Gloves	KL-Kepong Rubber Products Sdn. Bhd.	LYY	Class I	2003-01-24
K023831	Ucp Dental Material	Precious Chemicals U.S.A., Inc.	EJT	Class II	2003-01-24
K023826	Syntex Powder-Free Latex Examination Glove-Blue Color	Syntex Healthcare Products Co., Ltd.	LYY	Class I	2003-01-24
K023650	Insight Plus 9000 Phased Array Torso and Plevis Coil	GE Healthcare Coils	MOS	Class II	2003-01-24
K023642	Piccolo Total Cholesterol Test System	Abaxis Inc	CHH	Class I	2003-01-24
K023640	Piccolo Hdl Test System	Abaxis Inc	LBS	Class I	2003-01-24
K023639	Piccolo Triglycerides Test System	Abaxis Inc	JGY	Class I	2003-01-24
K023612	Silverlon Contact Wound Dressing	Argentum International, LLC	FRO	Unclassified	2003-01-24
K023568	Bd Phoenix Automated Microbiology System	Becton Dickinson & Co	LON	Class II	2003-01-24
K023512	Picus Ultrasound Imaging Systems	Pie Medical	IYN	Class II	2003-01-24
K023168	Wu's 3-Wheeled Neo Scooter, Wt-T3b	Wu's Tech Co., Ltd.	INI	Class II	2003-01-24
K023166	Wu's 3-Wheeled Neo Scooter, Wt-M4	Wu's Tech Co., Ltd.	INI	Class II	2003-01-24
K023148	Epw Powered Wheelchair, Gp-201	EMG Technology Co., Ltd.	ITI	Class II	2003-01-24
K023040	Wu's 3-Wheeled Neo Scooter, Wt-L3	Wu's Tech Co., Ltd.	INI	Class II	2003-01-24
K022697	Teh Lin Jupiter Power Chair, Model Tl-320	Teh Lin Prosthetic & Orthopaedic, Inc.	ITI	Class II	2003-01-24
K022445	Visera Hysterovideoscope Olympus Hyf Type V	Olympus Optical Co., Ltd.	HIH	Class II	2003-01-24
K022433	Neogenesys 2K	Sanexas Intl. GmbH	LIH	Class II	2003-01-24
K022192	Pegasus Nasal CPAP System	Sensor Medics Corp.	BZD	Class II	2003-01-24
K022052	40Lpm Abdominal Insufflator, Catalog # 72-00203-0	Northgate Technologies Inc.	HIF	Class II	2003-01-24
K021547	Flowline Biopore Eptfe Vascular Graft	Jotec GmbH	DSY	Class II	2003-01-24
K020586	Good Lubrications	Biofilm, Inc.	KMJ	Class I	2003-01-24
K012423	Mucograft	Ed. Geistlich Soehne AG Fuer Chemische Industrie	NPL	Class II	2003-01-24
K030089	Triage Cardiac Controls; Triage Cardio Profiler Controls	Biosite Incorporated	JJY	Class I	2003-01-23
K030047	Freedom Constrained Liners	Zimmer GmbH	KWZ	Class II	2003-01-23
K024326	Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System	Spinal Concepts, Inc.	KWQ	Class II	2003-01-23
K024234	Ascensia Glucofacts; Ascensia Glucofacts Professional	Bayer Corp.	NBW	Class II	2003-01-23
K024022	Osteo-Cable Sleeve	Zimmer GmbH	HXN	Class I	2003-01-23
K023941	Synthes Tomofix Osteotomy System	Synthes (USA) Products LLC	KTT	Class II	2003-01-23
K023934	Rapid Thermal Exchange System	Avacore Technologies, Inc.	DWJ	Class II	2003-01-23
K023804	Moss Miami Spinal System Pin Nut	Depuyacromed	KWP	Class II	2003-01-23
K023776	Xeno III Dental Adhesive	Dentsply Intl.	KLE	Class II	2003-01-23
K023743	Smith & Nephew Global Bipolar System	Smith & Nephew, Inc.	KWY	Class II	2003-01-23
K023678	Dimisil Scar Gel	Aesthetic and Reconstructive Technologies, Inc.	MDA	Class I	2003-01-23
K023613	Ax200 Automatic X-Ray Film Processor, Model 6586.036	Alphatek Corp.	IXW	Class II	2003-01-23
K023114	Lumend Frontrunner Cto Catheter	Lumend, Inc.	PDU	Class II	2003-01-23
K022602	Drx3000	Axiom USA., Inc.	ITH	Class II	2003-01-23
K022447	Bard Er Ureteral Stent with Suture	C.R. Bard Inc	FAD	Class II	2003-01-23
K022143	Interpore Cross International Anterior Fixation Device (Afd)	Interpore Cross Intl.	MQP	Class II	2003-01-23
K030064	Ilook 25 Needle Guide Attachment and Bracket Assembly	FUJIFILM SonoSite,Inc.	ITX	Class II	2003-01-22
K024248	Modification to Ebi Xfix Dfs System Metaphyseal Correction System	Ebi, LLC	KTT	Class II	2003-01-22
K024177	Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2003-01-22
K023930	Coopersurgical Oocyte Recovery Needles	CooperSurgical, Inc.	MQE	Class II	2003-01-22
K023850	Sydney Ivf Embryo Biopsy Medium	Cook Ob/Gyn	MQL	Class II	2003-01-22
K023751	Exajet	GC America Inc.	ELW	Class II	2003-01-22
K023618	Sonicaid One	Oxford Instruments Medical, Ltd.	HGM	Class II	2003-01-22
K023575	Concert Cranioplast	Immedica, Inc.	GXP	Class II	2003-01-22
K023128	Non-Spermicidal Lubricated Male Latex Condom	Secure Scientific Sdn Bhd	HIS	Class II	2003-01-22
K022884	Candela Smoothbeam Laser System	Candela Corporation	GEX	Class II	2003-01-22
K022365	Stryker Navigation System - Hip Module	Stryker Corp.	HAW	Class II	2003-01-22
K011754	Exel Securetouch Ptp Syringe	Exelint Intl. Co.	MEG	Class II	2003-01-22