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 1056 of 3531

510(k) clearances, page 1056 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092014	Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	DYB	Class II	2009-10-08
K091540	Mtd 4000	Mettler Electronics Corp	ITH	Class II	2009-10-08
K090361	Remote Infrared Thermometer, Model Rc002	Rycom Electron Technology Limited	FLL	Class II	2009-10-08
K090051	Levitronix Pedimag Blood Pump, Model 201-90052	Levitronix, LLC	KFM	Class II	2009-10-08
K093018	G-Prox Endoscopic Grasper, Model 205333	Usgi Medical	GAT	Class II	2009-10-07
K092516	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Zi BO Yuxiang Gloves Co., Ltd.	LYZ	Class I	2009-10-07
K092085	Ispira Resuscitation Unit	Neoforce Group, Inc.	BTL	Class II	2009-10-07
K091918	Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro	Genoray Co., Ltd.	OWB	Class II	2009-10-07
K091613	Take 1	Sybron Dental Specialties, Inc.	ELW	Class II	2009-10-07
K090724	Or-Light	Yperion Technology	ONF	Class II	2009-10-07
K092287	Nuvasive Spherx II - Pedicle Screw System	NuVasive Inc	NKB	Class II	2009-10-06
K092218	Flexicare Breathing Filters	Flexicare Medical Ltd.	CAH	Class II	2009-10-06
K092197	Photex30 Diode Laser Series: 980, 810, 940	Biotex, Inc.	GEX	Class II	2009-10-06
K092112	Bti Dental Implant Tiny 2.5-3.0	B.T.I. Biotechnology Institute, S.L.	DZE	Class II	2009-10-06
K092070	Interplate C	RSB Spine LLC.	KWQ	Class II	2009-10-06
K091907	Nobelprocera Implant Bridge Zirconia	Nobel Biocare AB	NHA	Class II	2009-10-06
K091878	Osseolink Dental Implant System	Global Implant Solutions, LLC	DZE	Class II	2009-10-06
K090716	Bego Semados S-Line	Bego Implant Systems GmbH & Co. KG	DZE	Class II	2009-10-06
K090841	Addplus	Ulrich GmbH & Co. KG	MQP	Class II	2009-10-05
K092729	Baxano Neuro Check Device	Baxano, Inc.	ETN	Class II	2009-10-02
K092676	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2009-10-02
K092471	Model Sentinella 102	General Equipment for Medical Imaging, S.A.	IYX	Class I	2009-10-02
K092111	Entomed Screening Audiometer, Model Sa201,sa202, Entomed Diagnostic Audiometer Model Sa203,sa204	Entomed AB	EWO	Class II	2009-10-02
K092082	Synergy Cannulated Screw System	Synergy Surgical Technologies, LLC	HWC	Class II	2009-10-02
K092058	Sonosite Nanomaxx Series Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2009-10-02
K092041	Stellar Fiducial Marker, Model Gfmia	Stellar Medical Corp.	IYE	Class II	2009-10-02
K092037	Lifegurney Network Patient Vigilance System	Hoana Medical, Inc.	DRT	Class II	2009-10-02
K092026	Easycare Tx, Tx Link	ResMed Corp	BZD	Class II	2009-10-02
K092016	Super-Fine Pen Needle	Stat Medical Devices, Inc.	FMI	Class II	2009-10-02
K091721	Cryosuccess, Model C-Suc-01, C-Suc-02, C-Dts-02, C-Dts-03, C-Gts-13. C-Ca-23	New Medical Technologies GmbH	GEH	Class II	2009-10-02
K091679	Leforte System Bone Plate	Jeil Medical Corporation	JEY	Class II	2009-10-02
K091386	Microfuse Dual Rate Infuser	Numia Medical Technology, LLC	FRN	Class II	2009-10-02
K091332	Aia-Pack Rbc Folate	Tosoh Bioscience Inc	CGN	Class II	2009-10-02
K091217	Dbx Demineralized Bone Matrix Putty	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	NUN	Class II	2009-10-02
K090919	Kensey Nash Fibrillar Collagen Dental Membrane	DSM Biomedical, Inc.	NPL	Class II	2009-10-02
K090712	Eocene System	Infopia Co, Ltd.	NBW	Class II	2009-10-02
K090568	Medline Nitrile Exam Gloves W/aloe -Green	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2009-10-02
K092867	Identium Heavy, Medium, Medium Soft, Light	Kettenbach GmbH & Co KG	ELW	Class II	2009-10-01
K092711	Guardian II Hemostasis Valve	Zerusa Limited	DTL	Class II	2009-10-01
K092678	Evision Data Management Software	Nonin Medical, Inc	DQA	Class II	2009-10-01
K092539	Seamfree	Apex Dental Materials, Inc.	EBF	Class II	2009-10-01
K092234	Dynesys Top-Loading Spinal System	Zimmer Spine, Inc.	NQP	Class II	2009-10-01
K092195	Cutera Multimodal Cellulite Product (Cmmcd)	Cutera Inc	NUV	Class II	2009-10-01
K092056	Optomed Smartscope, Model M3-1 Ey1	Optomed	HKI	Class II	2009-10-01
K091910	Piccolo Magnesium Test System	Abaxis Inc	JGJ	Class I	2009-10-01
K091789	Carto Rmt Ep Navigation System V8	Biosense Webster Inc	DQK	Class II	2009-10-01
K083927	Waterlase Md	Biolase MG LLC	GEX	Class II	2009-10-01
K092666	Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250	Boston Scientific Corporation	HCG	Class II	2009-09-30
K092161	Full Automatic (Nibp) Blood Pressure Monitor, Model Hl868bf	Health & Life Corporation	DXN	Class II	2009-09-30
K092003	Cpc Sleep Data Recorder, Model M1, and Application Software	Mycardio	MNR	Class II	2009-09-30