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 815 of 3530

510(k) clearances, page 815 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130874	Stryker Nav3i Platform	Stryker Corporate	HAW	Class II	2013-09-27
K130663	Bestfit2 Nasal Mask	Curative Medical, Inc.	BZD	Class II	2013-09-27
K130560	Mastertorque Lux 8900 L	Kaltenbach & Voigt GmbH	EFB	Class I	2013-09-27
K123822	Klein Touch Pump and Disposable Tubing Set	HK Surgical Inc	FRN	Class II	2013-09-27
K122219	Theyfit Male Condom	Theyfit	HIS	Class II	2013-09-27
K132777	Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter	Medtronic, Inc.	LIT	Class II	2013-09-26
K132701	Primi Support Catheter	Thermopeutix, Inc.	DQY	Class II	2013-09-26
K132700	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek	MAX	Class II	2013-09-26
K132654	Acuson Sc2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc. Ultrasound Gro	IYO	Class II	2013-09-26
K132278	Cochlear Baha 4 Sound Processor	Cochlear Americas	LXB	Class II	2013-09-26
K132133	Cg+ Arrow Jacc Powered by Arrow Vps Stylet	Arrow International (Subsidiary of Teleflex Inc.)	OBJ	Class II	2013-09-26
K132092	Esteya	Nucletron BV	JAD	Class II	2013-09-26
K132084	Protura Couch Software	Med-Tec, Inc. D/B/A Civco Medical Solutions	JAI	Class II	2013-09-26
K132068	Philips Dxl 12/16-Lead ECG Algorithm	Philips North America LLC	DPS	Class II	2013-09-26
K131885	Senographe Essential, Premium View I (Pvi)	GE Medical Systems SCS	MUE	Class II	2013-09-26
K131795	Nanor and Efficast/nanor Hybrid Thermoplastic Materials	Orfit Industries NV	IYE	Class II	2013-09-26
K131431	Airo CT System	Brainlab, Inc.	JAK	Class II	2013-09-26
K131411	Coseal	Jilin Coronado Medical, Ltd.	DXC	Class II	2013-09-26
K131388	Transcend Heated Humidifier	Somnetics International, Inc	BTT	Class II	2013-09-26
K130983	Genii Arc Smart Argon Probe	Genii, Inc.	GEI	Class II	2013-09-26
K130952	Precision One Lifecare; Detecto; Detecto	Precision One Lifecare, Ltd.	MNW	Class II	2013-09-26
K130275	Quikscreen Multi (Mdma and Opi) OTC Drug Cup Test	Tianjin New Bay Bioresearch Co., Ltd.	DJG	Class II	2013-09-26
K130150	Tcm Massager	Anhui Jinjianqiao Med-Tech Co,., Ltd.	NUH	Class II	2013-09-26
K124043	Lightlas Family of Multi-Wavelength Medical Laser System	Lightmed Corp.	HQF	Class II	2013-09-26
K122370	Contour Next Link Wireless Blood Glucose Monitor	Medrad, Inc.	NBW	Class II	2013-09-26
K121516	Virtuoso System for Ihc Her2 (4B5)	Ventana Medical Systems Inc	NQN	Class II	2013-09-26
K132665	Pelleve Glidesafe 10Mm, 15Mm & 20Mm Handpiece, Pelleve S5 - Iec	Ellman International, Inc.	GEI	Class II	2013-09-25
K132287	Jazz System	Hogan Lovells US LLP	OWI	Class II	2013-09-25
K131992	Multichem P	Techno-Path Manufacturing Ltd.	JJY	Class I	2013-09-25
K131965	Xvi R5.0	Elekta Limited	IYE	Class II	2013-09-25
K131891	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2013-09-25
K131873	Ndohd High Definition Imaging System (Ndohd)	MethodSense, Inc.	LLZ	Class II	2013-09-25
K131751	Finessis Violet Element Polyisoprene Powderfree Sterile Surgical Gloves	Lucenxia Prescience AG	KGO	Class I	2013-09-25
K131440	Powder Free Nitrile Patient Examination Gloves, Blue	Hebei Hongsen Plastics Technology Co, Ltd.	LZA	Class I	2013-09-25
K131289	I-Gen	Megagen Implant Co., Ltd.	JEY	Class II	2013-09-25
K130510	Arthrex Compression Plates	Arthrex GmbH	HRS	Class II	2013-09-25
K130455	430 Swl 45 and 430 Sw 45 High-Speed Handpieces	Dentalez Group, Stardental Division	EFB	Class I	2013-09-25
K121790	Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay System	Siemens Healthcare Diagnostics Inc.	MMI	Class II	2013-09-25
K132274	Aixplorer	Supersonic Imagine	IYN	Class II	2013-09-24
K132171	Aixplorer	Supersonic Imagine	IYN	Class II	2013-09-24
K131937	Voluson I/e	GE Healthcare	IYN	Class II	2013-09-24
K131773	Brilliance Ict	Philips Healthcare (Cleveland)	JAK	Class II	2013-09-24
K131685	Ge Echopac	GE Vingmed Ultrasound AS	LLZ	Class II	2013-09-24
K131529	Shengguang Manual Wheelchair	Pingdingshan Shenxing Healthcare Technology Co., L	IOR	Class I	2013-09-24
K130654	Crystal Ultra	Dental Laboratory Milling Supplies, LLC (Dlms)	EIH	Class II	2013-09-24
K123402	Diagnocam	Kaltenbach & Voigt GmbH	NTK	Class II	2013-09-24
K132692	Bd Veritor System for the Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2013-09-23
K132672	Extra Corporeal Shockwave Lithotripter	Dornier Medtech America, Inc.	LNS	Class II	2013-09-23
K132508	Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel	Centers for Disease Control and Prevention	OZE	Class II	2013-09-23
K132069	Desara Mesh, Desara Blue	Caldera Medical, Inc.	OTN	Class II	2013-09-23