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 1284 of 3531

510(k) clearances, page 1284 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K053338	Arthrex Titanium and Bio-Degradable (Polymer) Implants	Arthrex GmbH	HWC	Class II	2006-01-26
K053327	Oxicom Control	Bionostics, Inc.	JJX	Class I	2006-01-26
K053198	Simplex P Speedset Bone Cement	Howmedica Osteonics Corp	LOD	Class II	2006-01-26
K053021	Estech Clearview Mv Atrial Depressor	Estech, Inc.	DTS	Class II	2006-01-26
K052479	Mbath 1000 (60)	Enneking Medical, Inc.	ILJ	Class II	2006-01-26
K052442	Radiancy Skinstation with Psoriasis Light Unit Assembly	Radiancy (Israel), Ltd.	GEX	Class II	2006-01-26
K051447	Sentinel Pancreatic Amylase	Sentinel CH SpA	JFJ	Class II	2006-01-26
K042096	Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System	Misonix, LLC	NTB	Class II	2006-01-26
K053574	Medline Pediatric Wheelchairs	MEDLINE INDUSTRIES, LP - Northfield	IOR	Class I	2006-01-25
K053455	Encompass.net	Empiric Systems, LLC	LLZ	Class II	2006-01-25
K053379	Reli-on One Step, Orthodontic Adhesive	Classone Orthodontics, Inc.	DYH	Class II	2006-01-25
K053328	Biosplint Splinting Ribbon	Satelec	EBI	Class II	2006-01-25
K053274	Anatomical Shoulder Inverse/reverse	Zimmer GmbH	PHX	Class II	2006-01-25
K053180	Parallax Acrylic Resin Cartridge with Tracers	ArthroCare Corporation	NDN	Class II	2006-01-25
K052813	Fd TENS 2030, Model Dfj24t	FUJI Dynamics Limited	GZJ	Class II	2006-01-25
K052812	Ossimend (Tm) Bone Graft Material	Collagen Matrix, Inc	MQV	Class II	2006-01-25
K052666	Non-Sterile Powder Free Natural/green Lano-E Latex Exam Gloves, with or Wihout Citrus/peppermint Scent Plus a Protein	Ascend Eagle, Inc.	LYY	Class I	2006-01-25
K060096	Modular Trocar System	Applied Medical Resources Corp	GCJ	Class II	2006-01-24
K060087	Accuvix V7 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2006-01-24
K053648	Pioneer Tc8080, Companion III	Viasys Neuro Care	IYN	Class II	2006-01-24
K053641	Iba Proton Therapy System-Proteus 235	Ion Beam Applications S.A.	LHN	Class II	2006-01-24
K053606	Be Plus / Aura-Ltm64 Amplifier	EB Neuro S.p.A.	GWL	Class II	2006-01-24
K053309	Altaire Interventional Mr Package	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2006-01-24
K053235	Nsk Precision Apex Locator (Pal)	Medicsense USA	LQY	Unclassified	2006-01-24
K053185	Primo Noninvasive Blood Pressure Measurement System	Medwave, Inc.	DXN	Class II	2006-01-24
K053044	Opto Global Digital Fundus Camera System Model Ads 1.5	Opto Global, Inc.	HKI	Class II	2006-01-24
K052773	B. Braun 0.2 Micron Filter	B.Braun Medical, Inc.	FMF	Class II	2006-01-24
K052577	Ikoniscope Fastfish Amnio Imaging System	Ikonisys, Inc.	JOY	Class II	2006-01-24
K060050	Megabeam Sidefiber Fiber Optic Delivery System	Biolitec, Inc.	GEX	Class II	2006-01-23
K053643	Stage- 1 Temporary/healing Cap, Model 42021-42026	Lifecore Biomedical LLC	NHA	Class II	2006-01-23
K053022	Synthes (USA) Chronos-Beta-Tcp	Synthes (USA) Products LLC	LYC	Class II	2006-01-23
K052997	Zimmer Dental One-Piece Implant	ZimVie US Corp LLC	DZE	Class II	2006-01-23
K052878	Nt-1000	Neuro Therm, Inc.	GXD	Class II	2006-01-23
K052789	Triage Bnp Test for Beckman Coulter Immunoassay Systems, Model 98200	Biosite Incorporated	NBC	Class II	2006-01-23
K052762	Liberty Blood Glucose Monitoring System, Model 8000-0067	Agamatrix	NBW	Class II	2006-01-23
K052680	Calculase Holmium Laser System and Accessories	Karl Storz Endoscopy-America, Inc.	GEX	Class II	2006-01-23
K051677	Optigen Allergen Specific Ige Assay	Canon Medical Diagnostics USA, Inc.	DHB	Class II	2006-01-23
K050955	Lifesign Dxpress, Model Lsr2000	Princeton BioMeditech Corp.	JHI	Class II	2006-01-23
K060058	Stellar 404T	Larsen & Toubro Limited	MWI	Class II	2006-01-20
K060020	Autoquant Plus	Philips North America LLC	KPS	Class II	2006-01-20
K060001	D-10 Hemoglobin A1c Program; D-10 Dual Program	Bio-Rad Laboratories Inc.	LCP	Class II	2006-01-20
K053559	Pf4 Enhanced Solid Phase Elisa	Immucor GTI Diagnostics, Inc.	LCO	Class II	2006-01-20
K053557	Eska-Libur Hip Stem	Eska Implants GmbH	LPH	Class II	2006-01-20
K053332	Breath Alcohol Test System, Model Al 2500	Sentech Korea Corp.	DJZ	Class I	2006-01-20
K053243	Sensititre 18-24 Hours Susceptibility Plates	Trek Diagnostic Systems, Ltd.	LRG	Class II	2006-01-20
K052975	Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-Web04 Software	GE Healthcare	MSX	Class II	2006-01-20
K052854	Lifenet Exchange System	Physio Control, Inc.	MSX	Class II	2006-01-20
K052825	Visulize Factor VIII Antigen Kit, Model Fviii-Ag	Affinity Biologicals Inc.	GGP	Class II	2006-01-20
K052822	Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202	Thunder Tiger Corp.	EFB	Class I	2006-01-20
K051774	Mbcp	Biomatlante	MQV	Class II	2006-01-20