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 1228 of 3531

510(k) clearances, page 1228 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051817	Boomerang Closurewire Vascular Closure System	Cardiva Medical, Inc.	DXC	Class II	2006-12-06
K063457	Truehd (1080P) Digital Camera System	Conmed Linvatec	GCJ	Class II	2006-12-05
K063398	Esa Leadcare II Lead Control	Bionostics, Inc.	DIF	Class I	2006-12-05
K063313	Filterwire Ez Embolic Protection System (3.5 Mm to 5.5 Mm)	Boston Scientific Corporation	NTE	Class II	2006-12-05
K063213	Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves	Ever Light Plastic Products Co., Ltd.	LYZ	Class I	2006-12-05
K063116	Demetron A.2	Sybron Dental Specialties, Inc.	EBZ	Class II	2006-12-05
K063045	Immulite 2000, Immulite 2500 Vancomycin	Siemens Healthcare Diagnostics Inc.	LEH	Class II	2006-12-05
K062956	Ez-Mio, Ez-Io Distal Tibia	Teleflex Medical	FMI	Class II	2006-12-05
K062508	Neurowave Micro-Infusion System	Ekos Corp.	NUI	Class II	2006-12-05
K062435	Repair Kit for Xpresso, Decathlon, and Alta Lr Catheters	Spire Biomedical, Inc.	NFK	Class II	2006-12-05
K062100	Arjowrap 47/100 and 47/88	Arjo Wiggins Medical, Inc.	FRG	Class II	2006-12-05
K052719	Uritest 10 Urinalysis Reagent Strips	Arj Medical, Inc.	CDM	Class I	2006-12-05
K063419	Modification to Vsm- Vital Signs Monitor, (Vsm 300 )	Welch Allyn Protocol, Inc.	MWI	Class II	2006-12-04
K063308	Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200	Carbylan Biosurgery	LYA	Class I	2006-12-04
K063199	21.3-Inch (54Cm) Color Lcd Monitor Cdl2120a (Ccl252i2)	Totoku Electric Co., Ltd.	LLZ	Class II	2006-12-04
K063194	Tufflex Polyester Suture	TORNIER Inc.	GAT	Class II	2006-12-04
K063030	Comfort Scooter Model Ly-Ew406	Comfort Orthopedic Co., Ltd.	INI	Class II	2006-12-04
K062842	Twist Drill	Biomet Microfixation	HBE	Class II	2006-12-04
K062819	Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery	Bioplate Inc	GXN	Class II	2006-12-04
K062769	Pressurewire Certus, Models 12006 and 12306	Radi Medical Systems AB	DXO	Class II	2006-12-04
K062750	Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030	Boston Scientific Corporation	MUM	Class II	2006-12-04
K062518	Celerity	Parkell, Inc.	EBF	Class II	2006-12-04
K062371	Preview Anterior Cervical Plate System	Alphaspine, Inc.	KWQ	Class II	2006-12-04
K062045	Edia Anti-Ccp	Svar Life Science AB	NHX	Class II	2006-12-04
K061726	Lsc, Model 3	Lifestand	IPL	Class II	2006-12-04
K061466	Intimol	Dlc Laboratories, Inc.	NUC	Class II	2006-12-04
K063538	Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands	ArthroCare Corporation	GEI	Class II	2006-12-01
K063519	Dynamic Gas Scavenging System (Dgss)	Anesthetic Gas Reclamation, Inc.	CBN	Class II	2006-12-01
K063485	Logic Laparoscopic Scissors	Surgical Innovations Ltd	GEI	Class II	2006-12-01
K063469	Medican Alpha	Eastern Medikit, Ltd.	FOZ	Class II	2006-12-01
K063400	Variant II Turbo Hemoglobin A1c Program, Hemoglobin Testing System with Cdm 4.0	Bio-Rad Laboratories Inc.	LCP	Class II	2006-12-01
K063220	Da Vinci S Surgical System-V1.1, Model Is2000	Intuitive Surgical, Inc.	NAY	Class II	2006-12-01
K063112	Revlite Q-Switched Nd:yag Laser	Hoya Conbio, Inc.	GEX	Class II	2006-12-01
K063062	Hkbond 2006	Kulzer GmbH	KLE	Class II	2006-12-01
K063025	Lina Powerblade, Model 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,	LiNA Medical Inc	GEI	Class II	2006-12-01
K063013	Pleats Plus N95 Respirator, Models 1054 and 1054S	Aearo Company	MSH	Class II	2006-12-01
K063012	Ncontact Coagulation System Kit, Model Csk	Ncontact Surgical, Inc.	OCL	Class II	2006-12-01
K062960	Conserve Femoral Resurfacing Component	Wrightmedicaltechnologyinc	KXA	Class II	2006-12-01
K062719	Greenlight Hps Series Surgical Laser System & Accessories	Laserscope	GEX	Class II	2006-12-01
K062674	Mission Trinity B	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2006-12-01
K062539	Ncontact Coagulation System Kit	Ncontact Surgical, Inc.	GEI	Class II	2006-12-01
K061937	Cook Endoscopy Esophageal Dilation Balloon	Wilson-Cook Medical Inc.	KNQ	Class II	2006-12-01
K061712	Spirobank II	Mir Medical Intl. Research SRL	BZG	Class II	2006-12-01
K060792	Illumimed	Photoactif, LLC	ILY	Class II	2006-12-01
K063507	Syngo Neuro Pbv CT	Siemens Corp.	JAK	Class II	2006-11-30
K063448	EMG Ac/dc Suction Unit	EMG Technology Co., Ltd.	JCX	Class II	2006-11-30
K063342	Medrad Ecoil Imaging System for Philips	Medrad, Inc.	MOS	Class II	2006-11-30
K063312	Modification to Atlantis Sr Pro 2 and Sr Pro Coronary Imaging Catheters, Model 39014 and 38942	Boston Scientific Corporation	DQO	Class II	2006-11-30
K063277	Mapmate	Abbott Medical	DQK	Class II	2006-11-30
K063198	21.3-Inch (54Cm) Monochrome Lcd Monitor Mdl2121a (Me253i2)	Totoku Electric Co., Ltd.	LLZ	Class II	2006-11-30