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 1307 of 3531

510(k) clearances, page 1307 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051320	Satellite Spinal System	Medtronic Sofamor Danek	NVR	Class III	2005-09-09
K051269	Rii Infrared Ear Thermometer, Models Th00xy Series	Radiant Innovation Inc.	FLL	Class II	2005-09-09
K051130	Vcs S3y	Cycling and Health Tech. Industry R&D Center/Chc	INI	Class II	2005-09-09
K041820	Solo-Care Aqua Antimicrobial Lens Case	Alcon Laboratories	LRX	Class II	2005-09-09
K033231	Spina System	North American Medical Corp (Nam)	ITH	Class II	2005-09-09
K052337	Monochrome Lcd Monitor, Model Radiforce G33	Eizo Nanao Corporation	LLZ	Class II	2005-09-08
K052305	MRI Soft Tissue Motion Correction Software Va10a	Siemens Medical Solutions USA, Inc.	LNH	Class II	2005-09-08
K052260	Superdimension/bronchus 4.1	Medtronic, Inc.	JAK	Class II	2005-09-08
K052216	Somatom Definition	Siemens Medical Solutions USA, Inc.	JAK	Class II	2005-09-08
K052181	Modification to Xia Spinal System	Howmedica Osteonics Corp	KWP	Class II	2005-09-08
K052167	Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories	GE Healthcare	CCK	Class II	2005-09-08
K052158	Welch Allyn Cardioperfect Workstation Version 1.5.0 Software	Welch Allyn Inc	BZG	Class II	2005-09-08
K052154	Omron Automatic Blood Pressure Monitor, Model Hem-711Ac	Omron Healthcare Co., Ltd.	DXN	Class II	2005-09-08
K052153	Omron Automatic Blood Pressure Monitor, Model Hem-741Crel	Omron Healthcare Co., Ltd.	DXN	Class II	2005-09-08
K052150	Volar Plate System	Dvo Extremity Solutions, LLC	HRS	Class II	2005-09-08
K051986	Synthes 4.5 Mm Lcp Straight Reconstruction Plates	Synthes (USA) Products LLC	HRS	Class II	2005-09-08
K051956	Dr. Oppel St-501	Sometech Incorporated	GEI	Class II	2005-09-08
K051676	Spineassist Device with Additional Accessories	Mazor Surgical Technologies, Ltd.	HAW	Class II	2005-09-08
K051650	Stratus Cs Acute Care Mb Isoenzyme of Creatine Kinase (Ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak.	Siemens Healthcare Diagnostics Inc.	JHX	Class II	2005-09-08
K051407	Legend All-Poly Cup	Ortho Development Corp.	JDI	Class II	2005-09-08
K051297	Elecsys N-Mid Osteocalcin, Elecsys Osteocalcin Calset, Elecsys Osteocalcin Calcheck	Roche Diagnostics GmbH	NEO	Class II	2005-09-08
K051281	The Needle Catcher	E.D.Medical, Ltd.	HTD	Class I	2005-09-08
K051209	Levitronix Centrimag Back-Up Console	Levitronix, LLC	KFM	Class II	2005-09-08
K051134	Heartstart Mrx with Q-CPR Option, Models M3535a or M3536a	Philips North America LLC	MKJ	Class III	2005-09-08
K041952	Zivf-Aire	Zander Medical Supplies, Inc.	MQG	Class II	2005-09-08
K052159	Aida Compact II System	Karl Storz Endoscopy-America, Inc.	LLZ	Class II	2005-09-07
K052098	Connexus, .5Cc, Model 023000-005	IsoTis OrthoBiologics, Inc.	MQV	Class II	2005-09-07
K052078	Achieva, Intera and Panorama 1.0 Release 2-Series	Philips Medical Systems Nederland B.V.	LNH	Class II	2005-09-07
K052024	Nstrand Implantation Kit	North American Scientific, Inc.	KXK	Class II	2005-09-07
K051966	First Check Multi Drug Cup 7 for Marijuana (Thc), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy	Worldwide Medical Corp.	DKZ	Class II	2005-09-07
K051952	Eugenone	Scientific Pharmaceuticals, Inc.	EMA	Class II	2005-09-07
K051831	Gemini Surgical Control & Display System	Applied Surgical, LLC	GEI	Class II	2005-09-07
K051716	Vertebron Pss Pedicle Screw System	Vertebron, Inc.	KWP	Class II	2005-09-07
K051279	Caldyne, Inc. Exhalometer Ex100, Model Ex100	Caldyne, Inc.	BZK	Class II	2005-09-07
K051251	Infrared Ear Themometer, Models Dx6603, Dx66390	Shenzhen Dongdixin Technology Co., Ltd.	FLL	Class II	2005-09-07
K051112	Whittlestone Expresser	Whittlestone, Inc.	HGX	Class II	2005-09-07
K050388	Refix Internal Fracture Fixation Screws	Xtremi-T, LLC	HWC	Class II	2005-09-07
K050174	Bio-Stim Kit	Skylark Device & Systems Co., Ltd.	GZJ	Class II	2005-09-07
K042287	Uniplain & Unichrom	United Medical Industries Co. Ltd.	GAL	Class II	2005-09-07
K052237	Sc Ceramic Ball Heads	Orthopedic Alliance, LLC	LZO	Class II	2005-09-06
K052209	Vcs Doppler Transceiver, Model 09-0023-01	Vascular Control Systems, Inc.	DPW	Class II	2005-09-06
K052185	Destination Carotid Guiding Sheath	Terumo Medical Corp.	DYB	Class II	2005-09-06
K052005	R&r External Fixation System	R&R Medical Corporation Ltd.	KTT	Class II	2005-09-06
K051975	Porous Coated Discovery Elbow	Zimmer GmbH	JDC	Class II	2005-09-06
K051945	Miot Plating System	Orthofix SRL	HRS	Class II	2005-09-06
K051915	Freelite Human Kappa and Lambda Free Kits for Use on the Bayer Advia 1650 Analyzer	The Binding Site	DFH	Class II	2005-09-06
K051866	Premier Temporary Cement	Premier Dental Products Co	EMA	Class II	2005-09-06
K051820	Parallax Ezflow Cement Delivery System	ArthroCare Corporation	OAR	Class I	2005-09-06
K051775	Osteomimetic Synthetic Bone Matrix	Biomimetic Pharmaceuticals, Inc.	MQV	Class II	2005-09-06
K051747	Sbi Wristfit	Small Bone Innovations, Inc.	HRS	Class II	2005-09-06