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 1802 of 3531

510(k) clearances, page 1802 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982398	Biomet 100% Porous Coated Biaxial Total Elbow	Zimmer GmbH	JDC	Class II	1998-08-11
K982286	Powderfree Green Latex Examination Gloves (Polymer Coated)	Besglove Medicare Sdn. Bhd.	LYY	Class I	1998-08-11
K982274	Nitrile Patient Examination Glove Powder Free	Asia Pacific Latex Sdn Bhd	LZA	Class I	1998-08-11
K982077	Selector Diagnostic Catheter	Boston Scientific Corporation	DQO	Class II	1998-08-11
K981879	Powdered Nitrile Examination Gloves	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-08-11
K981878	Powderfree Nitrile Examination Gloves (Polymer Coated)	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-08-11
K981877	Nitrile Powderfree Examination Gloves	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-08-11
K981869	Pro-Flex Disposable Prophy Angle	Professional Dental Mfg., Inc.	EFB	Class I	1998-08-11
K981823	Operating Room Towels	Baldur Systems Corp.	KKX	Class II	1998-08-11
K981808	Breathaid Tongue Scraper	Breathaid, LLC	LCN	Class I	1998-08-11
K981681	Prisma Cfm (Continuous Fluid Management System)	Gambro Healthcare	KDI	Class II	1998-08-11
K980909	Vichy Shower	Bouvier Hydro, Inc.	ILJ	Class II	1998-08-11
K980854	Retrograde Pediatric Nail	Encore Orthopedics, Inc.	HTY	Class II	1998-08-11
K980734	Myelotec Video Guided Catheter	Myelotec, Inc.	HRX	Class II	1998-08-11
K980453	Schneider Guider Softip Guiding Catheters	Boston Scientific Corporation	DQY	Class II	1998-08-11
K980049	Bonetrap	Bladhs Plast AB	EIA	Class I	1998-08-11
K982710	Aecd Arrhythmia Detection Software	ZOLL Medical Corporation	MKJ	Class III	1998-08-10
K982415	Cordis Webster Ref-Star External Reference Patch, Model # D-1210	Cordis Webster, Inc.	DRF	Class II	1998-08-10
K982313	Horizon Titanium Clips, Horizon Tantalum Clips	Weck Closure Systems	FZP	Class II	1998-08-10
K982201	Zenith Luxacore Automix Core Material (Multiple)	Foremost Dental Mfg., Inc.	EBF	Class II	1998-08-10
K982164	Estenia	Kuraray America, Inc.	EBF	Class II	1998-08-10
K981855	Prince Medical Cement Plug	Prince Medical, Inc.	JDI	Class II	1998-08-10
K981663	Digital Doc	Digital Doc LLC	EIA	Class I	1998-08-10
K973941	Immunowell Ebna Igg Test	Genbio	LLM	Class I	1998-08-10
K973940	Immunowell Ebv Vca Igg Test	Genbio	LSE	Class I	1998-08-10
K973939	Immunowell Vca Igm Test	Genbio	LJN	Class I	1998-08-10
K981647	3M Dent II System	3M Company	EBF	Class II	1998-08-09
K982686	Modification to Townley Pedicle Screw Plating System	Sofamor Danek USA,Inc.	MNI	Class II	1998-08-07
K982635	Caredop II	Nicolet Biomedical, Inc.	JAF	Class II	1998-08-07
K982498	Diagnostic Ultrasound System	Volumetrics Medical Imaging, Inc.	IYN	Class II	1998-08-07
K982301	Micro21 with Urine Sediment Analysis	Triangle Biomedical Sciences, Inc.	JOY	Class II	1998-08-07
K982249	Interacoustics Model Ad229 Diagnostic Audiometer	Idem (Int'L Dist. of Electronics for Medicine)	EWO	Class II	1998-08-07
K982130	Return Electrode Clamp Shell Cord Model Rc 201	New Deantronics, Ltd.	GEI	Class II	1998-08-07
K982018	Light Saber Aspiration Needle	Minrad, Inc.	FMF	Class II	1998-08-07
K981844	Sleep Management System	Rmp, Inc.	HCC	Class II	1998-08-07
K981805	Pos T-7000	Pos Technologies, Inc.	HCS	Class II	1998-08-07
K981790	Iview Electronic Portal Imaging Device (Epid) Model Number Ivew	Elekta Oncology Systems, Ltd.	IYE	Class II	1998-08-07
K981686	Stealthstation System Digitizer Change	Surgical Navigation Technologies, Inc.	HAW	Class II	1998-08-07
K981198	Medtronic Zuma Guiding Catheter	Medtronics Interventional Vascular	DQY	Class II	1998-08-07
K980504	Emcee Introducer Sheath, Dilator, Obturator, Introducer Set	Schneider/Namic	DYB	Class II	1998-08-07
K980423	Sonopsy La System	Neovision Corp.	IYO	Class II	1998-08-07
K980016	Millennium Valve Introducer/rotator Handle	Genzyme Surgical Product (Genzyme Biosurgery)	MOP	Class I	1998-08-07
K974588	Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral Transcranial Doppler Device, Compact Mod	Rimed, Ltd.	IYN	Class II	1998-08-07
K973705	Contor Table Surface	Hill-Rom Inc.	DWJ	Class II	1998-08-07
K982471	B2-Microglobulin Control Set Serum	Boehringer Mannheim Corp.	JJX	Class I	1998-08-06
K982399	Disetronic Penfine Injection Pen Needle	Disetronic Medical Systems	FMI	Class II	1998-08-06
K982295	Nidek Lightscan	Nidek, Inc.	GEX	Class II	1998-08-06
K982287	Aslan Sensor Modular Instrument	Aslan Medical Technologies, Ltd.	GCJ	Class II	1998-08-06
K982036	Silon Scar Strips	Bio Med Sciences, Inc.	MDA	Class I	1998-08-06
K982011	Depuy Motech Moss Miami Spinal System	Depuy Orthopaedics Inc.	KWP	Class II	1998-08-06