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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 628 of 3529

510(k) clearances, page 628 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160985	Pantera Pro	BIOTRONIK AG	LOX	Class II	2016-10-07
K160912	Sterilization Tray	STERIS Corporation	KCT	Class II	2016-10-07
K160864	Cryotop Vitrification Kit and Cryotop Thawing Kit	Kitazato Biopharma Co., Ltd.	MQL	Class II	2016-10-07
K160186	EnSite Velocity Surface Electrode Kit	Abbott Medical	DQK	Class II	2016-10-07
K160116	SpiroScout	Ganshorn Medizin Electronic GmbH	BZG	Class II	2016-10-07
K160100	Prestige Ameritech Pediatric/Child’s Face mask	Prestige Ameritech	OXZ	Class II	2016-10-07
K160062	AUTION ELEVEN Semi-Automated Urinalysis System	Arkray, Inc.	JIL	Class II	2016-10-07
K162547	Viveve System	Viveve, Inc.	GEI	Class II	2016-10-06
K162519	1717Wcc / 1717Wgc	Rayence Co., Ltd.	MQB	Class II	2016-10-06
K162518	1012Wcc, 1012Wgc	Rayence Co., Ltd.	MQB	Class II	2016-10-06
K162209	Sapphire NC Plus	Orbusneich Medical, Inc.	LOX	Class II	2016-10-06
K161976	Ziehm Solo FD	Ziehm Imaging GmbH	OWB	Class II	2016-10-06
K161937	CuattroDR	Cuattro Imaging, LLC	KPR	Class II	2016-10-06
K161684	Quantum LB	Reliance Orthodontic Products, Inc.	DYH	Class II	2016-10-06
K161584	ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16	Asahi Intecc Co., Ltd.	DQX	Class II	2016-10-06
K161471	MR Syringe Dual Pack for Solaris Injectors	Coeur, Inc.	DXT	Class II	2016-10-06
K161447	HydroSet XT	DSM Biomedical, Inc.	MQV	Class II	2016-10-06
K161330	Pour Acrylic	Dentsply Sirona Inc	EBI	Class II	2016-10-06
K161109	iSR'obot MRI-US Fusion	Biobot Surgical Pte. Ltd.	LLZ	Class II	2016-10-06
K160246	SimulCare II(TM)	Xanacare Technologies, LLC	GZJ	Class II	2016-10-06
K160217	uVue HSG/SHG Catheter	Cook Incorporated	LKF	Class II	2016-10-06
K160174	I.B.S. 2.0 Osteosynthesis screw	In2Bones SAS	HWC	Class II	2016-10-06
DEN150059	APAS Compact with Urine Analysis Module	Clever Culture Systems Limited	PPU	Class II	2016-10-06
K161925	CO2 Laser Therapy Machine	Beijing Adss Development Co., Ltd.	GEX	Class II	2016-10-05
K161885	The Cellfina System	Merz North America, Inc.	OUP	Class II	2016-10-05
K161560	Fingertip Pulse Oximeter MD300CN310	Beijing Choice Electronic Technology Co., Ltd.	DQA	Class II	2016-10-05
K161480	R2 Dermal Cooling System	R2 Dermatology	GEH	Class II	2016-10-05
K161241	e-fix E35/E36	Alber GmbH	ITI	Class II	2016-10-05
K160666	Dentiq3D	3D Industrial Imaging Co., Ltd.	LLZ	Class II	2016-10-05
K160327	Aladdin Hw3.0	VISIA imaging S.r.l.	HJO	Class II	2016-10-05
K153769	R:GEN Laser System	Lutronic Corporation	HQF	Class II	2016-10-05
K151995	Painmaster MCT Patch	Newmark, Inc.	NUH	Class II	2016-10-05
K162494	CD HORIZON® Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2016-10-04
K161897	PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2016-10-04
K161854	Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS	The Binding Site Group Ltd.	PCN	Class II	2016-10-04
K161727	Eyenez Ophthalmic Camera	Eyenez, LLC	HKI	Class II	2016-10-04
K161075	Arrow Epidural Catheter Kit	Teleflexmedical, Inc.	CAZ	Class II	2016-10-04
K161050	ACTABOND Topical Skin Adhesive	Bergen Medical Products, Inc.	MPN	Class II	2016-10-04
K160909	ATTO Mobility Scooter	Moving Life Ltd	INI	Class II	2016-10-04
K160731	LumFix Spinal Fixation Sytem	CG Bio Co., Ltd.	MNI	Class II	2016-10-04
K162549	Lumify Ultrasound System	Philips Health Care	IYN	Class II	2016-10-03
K162504	Skr 3000	Konica Minolta, Inc.	MQB	Class II	2016-10-03
K162269	Voluson E6, Voluson E8, Voluson E10	GE Healthcare	IYN	Class II	2016-10-03
K161881	PreXion3D Excelsior	Prexion Corporation	OAS	Class II	2016-10-03
K161828	kneeEOS	Onefit Medical	LLZ	Class II	2016-10-03
K161458	Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care	Indiba USA, Inc.	PBX	Class II	2016-10-03
K160060	DMi Dental Implant System	Dmi Innovative Medical Technology, Ltd.	DZE	Class II	2016-10-03
K153760	Volumetric Infusion Controller	Deka Research & Development Corp.	LDR	Class II	2016-10-03
K153539	RS80A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2016-10-03
K152970	Dynarex Xeroform Petrolatum Dressing	Dynarex Corp.	FRO	Unclassified	2016-10-03