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 2026-10-26, 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 754 of 3530

510(k) clearances, page 754 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133983	Intra. Ox Handheld Tissue Oximeter	Vioptix, Inc.	MUD	Class II	2014-09-12
K141601	Iassist Knee System	Zimmer CAS	OLO	Class II	2014-09-11
K141425	Elite + Laser System	Cynosure, LLC	GEX	Class II	2014-09-11
K141079	Optimedica Catalys Precision Laser System	OptiMedica Corp.	OOE	Class II	2014-09-11
K140991	Ranfac Aspiration Needle with Adjustable Guide	Ranfac Corp.	KNW	Class II	2014-09-11
K140841	Tablo Cartridge	Home Dialysis Plus	FJK	Class II	2014-09-11
K140429	Crane Acrylic Herbst Appliance	Crane Dental Laboratory	LRK	Class II	2014-09-11
K134019	Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector, Medisystems Onesite Dual Lumen Butto	NxStage Medical Inc	FIE	Class II	2014-09-11
K142423	EyeSuite Imaging	Haag-Streit AG	NFJ	Class II	2014-09-10
K142259	Direxion Torqueable Microcatheter	Boston Scientific Corporation	KRA	Class II	2014-09-10
K142230	Apollo Suture Anchor System and Titan Screws	Valeris Medical	MBI	Class II	2014-09-10
K142213	Via Spinous Process Fixation System	Spineology, Inc.	PEK	Class II	2014-09-10
K141937	Trident Fusion Implant	Vilex LLC	HWC	Class II	2014-09-10
K141835	Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods	Spineart SA	MNI	Class II	2014-09-10
K141565	Globe-Trotter Gt5400	Draeger Medical Systems, Inc.	FPL	Class II	2014-09-10
K141464	Novaguard S a Safety System	West Pharmaceutical Services, Inc.	MEG	Class II	2014-09-10
K140866	Tablo Console	Home Dialysis Plus	KDI	Class II	2014-09-10
K140780	Kegel Smart, Kegelsmart Pearl	Regulatory Insight, Inc.	HIR	Class II	2014-09-10
K140488	Contact Lens Case	Maca Plastics, Inc.	LRX	Class II	2014-09-10
K140390	Titanium Versa-Dial Humeral Head Prosthesis	Biomet Manufacturing Corp	MBF	Class II	2014-09-10
K140195	Surgical Drape	Griffith-Lucas, LLC	KKX	Class II	2014-09-10
K140167	Renaissance X System	Mazor Robotics Ltd	OLO	Class II	2014-09-10
K134040	Btl-9000; Btl-9000 Radiofrequency Module	BTL Industries, Inc	OLI	Class II	2014-09-10
K131983	Itrac Cervical Traction System	Pivotal Health Solutions	ITH	Class II	2014-09-10
K130742	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Dahoon Plastic Co., Ltd.	LYZ	Class I	2014-09-10
K142395	SC2000 and ACUSON X300 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYO	Class II	2014-09-09
K142182	Frimap Adapter Connector (Mac)	Topera, Inc.	MTD	Class II	2014-09-09
K141706	Ecare Coordinator (Ecc)	Visicu, Inc.	DRG	Class II	2014-09-09
K141244	Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological Indicator Spore Strips (Single Species)	North American Science Assoc., Inc.	FRC	Class II	2014-09-09
K141156	Spacelabs Healthcare Telemetry Receiver	GE Healthcare	MHX	Class II	2014-09-09
K141068	Zeiss Cataract Suite Markerless	Carl Zeiss Meditec Inc	HJO	Class II	2014-09-09
K133976	Fujifilm Endoscopic CO2 Regulator	FUJIFILM Healthcare Americas Corporation	FCX	Class II	2014-09-09
K133963	Surgiseal Twist (Tm) Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2014-09-09
K131340	Powder Free Yellow Synthetic Vinyl Patient Examination Gloves	Made Plastic Co., Ltd.	LYZ	Class I	2014-09-09
K141924	Hd Blood Pressure Monitor	Biocare Asia Corporation, Ltd.	DXN	Class II	2014-09-08
K141873	Range/mesa/denali Spinal System	K2M, Inc	NKB	Class II	2014-09-08
K141551	Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees)	Stryker Corporate	PGW	Class II	2014-09-08
K141541	Xidf-Aws801, Angio Workstation, V5.31	Toshibamedical Systems Corporation	JAA	Class II	2014-09-08
K141337	Arena-C	SPINEFRONTIER, Inc. dba LESspine Innovations	ODP	Class II	2014-09-08
K133584	In Touch Blood Glucose Monitoring System	Eoshealth, Inc.	CGA	Class II	2014-09-08
K142157	Palacos R+g Pro	Heraeus Medical GmbH	LOD	Class II	2014-09-05
K142127	Elecsys Estradiol III Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2014-09-05
K142105	Eli 380 Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2014-09-05
K142035	Glucocard 01-Mini Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System	ARKRAY Factory, Inc.	NBW	Class II	2014-09-05
K141824	Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft Strip	Medtronic Sofamor Danek	MQV	Class II	2014-09-05
K141574	Artis Zee/zeego Sw Vc21	Siemens Medical Solutions USA, Inc.	OWB	Class II	2014-09-05
K141572	Mosaiq Oncology Information System	Elekta Limited	IYE	Class II	2014-09-05
K141562	Msn-006	GC America Inc.	EBG	Class II	2014-09-05
K141552	Achieve Programmable Auomated Biopsy Systems	Care Fusion	KNW	Class II	2014-09-05
K141343	Axxent Cervical Applicator	iCAD, Inc.	JAD	Class II	2014-09-05