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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 797 of 3530

510(k) clearances, page 797 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132731	Digifix External Fixation System	Virak Orthopedic Research, LLC	JEC	Class II	2014-01-10
K132660	Nerve Cuff	Cook Biotech Incorporated	JXI	Class II	2014-01-10
K132403	Annextm Adjacent Level System	Spine Wave Inc	MNH	Class II	2014-01-10
K132346	Ultrasound Scanner Pro Focus 2202	BK Medical ApS	IYO	Class II	2014-01-10
K132335	Ultrasound Scanner Flex Focus 1202	BK Medical ApS	IYN	Class II	2014-01-10
K132210	Fujifilm 600 Series Endoscopes	FUJIFILM Healthcare Americas Corporation	FDF	Class II	2014-01-10
K132130	Reagent, Russel Viper Venom - La Screen	Dsrv, Inc.	GIR	Class I	2014-01-10
K132076	Reagent, Russel Viper Venom - La Confirm	Dsrv, Inc.	GIR	Class I	2014-01-10
K132071	Bioactive Bone Graft Putty	Biostructures, LLC	MQV	Class II	2014-01-10
K130662	Et Prosthetic System	OSSTEM Implant Co., Ltd.	NHA	Class II	2014-01-10
K130235	Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty	Hans Biomed Corp.	NUN	Class II	2014-01-10
K130168	Cl10009 Ir Laser	Curae'Lase, Inc.	ILY	Class II	2014-01-10
K130087	Panpac Word/bartholin Catheter	Panpac Medical Corporation	KNA	Class II	2014-01-10
K133520	Hammerlock 2	Biomedical Enterprises, Inc.	HTY	Class II	2014-01-09
K133371	Rampart-L	Spineology, Inc.	MAX	Class II	2014-01-09
K133321	Alamo C	Alliance Partners, LLC	ODP	Class II	2014-01-09
K133286	Midline (Tm)	Centinel Spine, LLC	OVD	Class II	2014-01-09
K133261	Medos Hilite 7000 & 7000 Lt Oxygenator	Medos Medizintechnik AG	DTZ	Class II	2014-01-09
K133256	Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System	ConforMIS, Inc.	JWH	Class II	2014-01-09
K133244	Tampax M Plastic Tampons, Unscented	Procter & Gamble Co.	HEB	Class II	2014-01-09
K132834	Fastep S10 Hcg Serum/urine Combo Test	Polymed Therapeutics, Inc.	JHI	Class II	2014-01-09
K132729	ISO-Gard Mask	Teleflexmedical, Inc.	CBN	Class II	2014-01-09
K131958	Bausch & Lomb Injector System	Bausch & Lomb Incorporated	MSS	Class I	2014-01-09
K131554	Rx Daytona Plus Chemistry Analyzer; Rx Daytona Plus Aspartate Aminotransferase (Ast) Reagent	Randox Laboratories, Limited	JJE	Class I	2014-01-09
K130888	Sonopulse/ Sonopulse III	Ibramed- Industria Brazileria de Equipamentos Medi	IMI	Class II	2014-01-09
K130851	Cascade Hemodialysis/apheresis Catheter	Health Line International Corporation	MSD	Class II	2014-01-09
K123986	Actim Prom	Alere Scarborough, Inc.	OAM	Class I	2014-01-09
K122982	Cryolock	Biotech, Inc.	MQK	Class II	2014-01-09
K121235	Leibinger Advance Internal Midface Distraction System	Stryker Corp.	JEY	Class II	2014-01-09
K133762	Endo Gia(tm) Extra Long Adapter	Medtronic, Inc.	GDW	Class II	2014-01-08
K133750	Occluder Occlusion Balloon Catheter	Boston Scientific Corporation	EYB	Class II	2014-01-08
K133747	Endochoice Water Bottle Cap Irrigation System	Boston Scientific Corporation	FEQ	Class II	2014-01-08
K133452	Emerge Medical Small Fragment Locked Plating System	Emerge Medical	HRS	Class II	2014-01-08
K133049	3I T3(r) External Hex Dental Implants	ZimVie US Corp LLC	DZE	Class II	2014-01-08
K132880	Medcomp Power Injectable Safety Huber Needle	Medical Components, Inc.	FPA	Class II	2014-01-08
K132843	Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)	Luminex Corporation	PEN	Class II	2014-01-08
K132247	Ultrasonic Mesh Nebulizer	Foshan Gaunying Electronics Co., Ltd	CAF	Class II	2014-01-08
K131000	V-Patch System	Intelesens Limited	DSI	Class II	2014-01-08
K130843	Safesept Needle Free Transseptal Trocar Guidewire	Oscor Inc.	DRC	Class II	2014-01-08
K130681	Endovascular Laser Venous System Kit with 2 Ring Radial Emitting Fiber	Biolitec SIA	GEX	Class II	2014-01-08
K130476	Orthodontic Miniscrew for Absolute Anchorage	Dental Morelli	OAT	Class II	2014-01-08
K133736	Endoscopic Suture Cutter	United States Endoscopy Group, Inc.	OCZ	Class II	2014-01-07
K133413	Idss Slc	Black Diamond Video, Inc.	FTA	Class II	2014-01-07
K133167	Monopolar Cautery Cord, Bipolar Cautery Cord	Intuitive Surgical, Inc.	GEI	Class II	2014-01-07
K132735	Axia Radial Head System	Imds (Innovative MEdical Device Systems) - Leis ME	KWI	Class II	2014-01-07
K132677	Ultrasound Scanner Flex Focus 1202	BK Medical ApS	IYN	Class II	2014-01-07
K132581	Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple Cartridge	Cardica, Inc.	GDW	Class II	2014-01-07
K132296	D-Rad Smart Pack	Smith & Nephew, Inc.	HRS	Class II	2014-01-07
K131832	Powder-Free Vinyl Patient Examination Gloves	Shandong Binxiang Medical Products Co., Ltd.	LYZ	Class I	2014-01-07
K130122	Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter	Siemens Healthcare Diagnostics Inc.	CFN	Class II	2014-01-07