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 2026-11-02, 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 1054 of 3531

510(k) clearances, page 1054 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090866	Neurocalm Model 1 and 2	Neuromed Devices, Inc.	GZJ	Class II	2009-10-21
K082756	Raven Protest - Steam Biological Indicator	Raven Biological Laboratories, Inc.	FRC	Class II	2009-10-21
K092561	Rejuvenate Modular Stem	Howmedica Osteonics Corp	MEH	Class II	2009-10-20
K092289	Ems Air-Flow Handy Perio	E.M.S. - Electro Medical Systems SA	EFB	Class I	2009-10-20
K092221	Colonic Splinting Overtube, Model 00711145	United States Endoscopy Group, Inc.	FED	Class II	2009-10-20
K091777	Alcon Ultrachopper	Alcon Laboratories	HQC	Class II	2009-10-20
K091542	Estech Easyflow Cannula with Guidewire	Endoscopic Technologies, Inc. D/B/A Estech	DWF	Class II	2009-10-20
K090703	Poly-Chem 90 Glucose	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	CFR	Class II	2009-10-20
K083163	Omni 2 Oxygen System	Sequal Technologies, Inc.	CAW	Class II	2009-10-20
K082891	Lenstar, Model Ls900	Haag-Streit AG	HJO	Class II	2009-10-20
K092898	Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi Sutures	Conmed Linvatec	MAI	Class II	2009-10-19
K092895	Apex Hp M Adult Hollow Fiber Membrane Oxygenator	Corcym Inc.	DTZ	Class II	2009-10-19
K092034	Powder Free Nitrile Examination Gloves, Black	Pt. Smartglove Indonesia	LZA	Class I	2009-10-19
K090487	Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model Sy-125, C855-5150	Coeur, Inc.	DXT	Class II	2009-10-19
K090474	Orthorex Intra-Operative Load Sensor	Orthosensor, Inc.	ONN	Class II	2009-10-19
K083626	Distractable Wave Cage	Advanced Medical Technology, Inc.	MAX	Class II	2009-10-19
K092913	Ep-4Tm Cardiac Stimulator, Models: Ep-04-02, Ep-04-04	Abbott Medical	JOQ	Class II	2009-10-16
K092879	Ligasure 5Mm Blunt Tip Laparoscopic Sealer-Divider	Medtronic, Inc.	GEI	Class II	2009-10-16
K092876	Sjm Attune Annuloplasty Ring	Abbott Medical	KRH	Class II	2009-10-16
K092570	Abx Pentra Tpu Cal, Model A11a01898	Horiba Abx SAS	JIT	Class II	2009-10-16
K092337	Pain Management Optima, Model Pmo21-100-05, Pmo20-100-10Cs, Pmo20-145-10Cs	Baylis Medical Co., Inc.	GXI	Class II	2009-10-16
K092280	Cypher Dicom Print Solution	Virtual Imaging, Inc.	LMC	Class II	2009-10-16
K092039	Identevent, Version 1.0G	Optima Neuroscience, Inc.	OMB	Class II	2009-10-16
K091848	Nobel/procera Implant Bridge	Nobel Biocare AB	NHA	Class II	2009-10-16
K091846	Synchron Systems G7 Amylase (Amy7) Reagent with Model(s) A71607	Siemens Healthcare Diagnostics Inc.	JFJ	Class II	2009-10-16
K091833	Gem-Stone Abdominal Training System; Model Gem-Tone 310Pe/320pe/330pe/340pe/350pe.	Gemore Technology Co., Ltd.	NGX	Class II	2009-10-16
K091781	Guided Medical Positioning System (Gmps)	Mediguide, Ltd.	DQK	Class II	2009-10-16
K091780	Guided Measurement Catheter (Gmc)	Mediguide, Ltd.	DQO	Class II	2009-10-16
K091516	Well Lead Silicone Catheter with Temperature Sensor	Well Lead Medical Co. Ltd	EZL	Class II	2009-10-16
K091065	Air Torx, Model Tra-200, Tra-200-Cp3, Tra-200-Cp4	J. Morita USA, Inc.	EFB	Class I	2009-10-16
K083260	Elecsys Myoglobin Stat, and Elecsys Myoglobin	Roche Diagnostics GmbH	DDR	Class II	2009-10-16
K081265	Thai Nippon Male Latex Condom	Thai Nippon Rubber Industry Co., Ltd.	HIS	Class II	2009-10-16
K092838	Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8	Masimo Corporation	DQA	Class II	2009-10-15
K092691	Dc-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	ITX	Class II	2009-10-15
K092336	C-Thru Spinal System	Ebi, LLC	MQP	Class II	2009-10-15
K092177	Mo.ma Ultra Proximal Cerebral Protection Device, Model Mus0130069x6	Invatec S.p.A.	NTE	Class II	2009-10-15
K092035	Bicon Implants with a 2.5Mm Internal Connection	Bicon, LLC	DZE	Class II	2009-10-15
K091624	Stent Graft Balloon Catheter	Via Biomedical, Inc.	DQY	Class II	2009-10-15
K091471	Patient Examination Gloves, Powder-Free Vinyl	Cartagloves S.A.	LYZ	Class I	2009-10-15
K091458	Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104	Medtronic, Inc.	MJN	Class II	2009-10-15
K090008	Tanda Restore, Model Ptscs	Pharos Life Corporation	ILY	Class II	2009-10-15
K090006	Lifebridge B2t, Model 7001	Lifebridge Medizintechnik AG	DTQ	Class II	2009-10-15
K092408	Rhythm of Life, Model R0901-05	Rapid Response Solutions, LLC	LIX	Class II	2009-10-14
K092156	Cad 12, Colonoscopy Assist Device	Softscope Medical Technologies, Inc.	FED	Class II	2009-10-14
K091703	Hd Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131	Concentric Medical, Inc.	QEZ	Class II	2009-10-14
K091420	Fraxel Re: Store Laser System, Model Sr1500	Solta Medical, Inc.	ONG	Class II	2009-10-14
K091369	Electrofluidgraph	Akern USA, LLC	MNW	Class II	2009-10-14
K091140	Ez-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-Io	Teleflex Medical	FMI	Class II	2009-10-14
K091091	Sonicfill 2010	Sybron Dental Specialties, Inc.	EBF	Class II	2009-10-14
K090472	Grind Guard	Archtek, Inc.	MQC	Unclassified	2009-10-14