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 631 of 3529

510(k) clearances, page 631 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161455	Catalys Precision Laser System	OptiMedica Corp.	OOE	Class II	2016-09-20
K161344	GentleCath Glide Intermittent Catheter	ConvaTec Limited	KOD	Class II	2016-09-20
K161086	Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)	Sterilmed Inc	NUJ	Class II	2016-09-20
K160919	Hansen Medical Magellan Robotic Catheter 9Fr	Hansen Medical, Inc.	DRA	Class II	2016-09-20
K153505	F&P Eson 2 Nasal Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2016-09-20
K162497	5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR	Eizo Corporation	PGY	Class II	2016-09-19
K161625	PixelShine	Algomedica	LLZ	Class II	2016-09-19
K161262	Super Distal Access (SDA)	Inneuroco, Inc.	DQY	Class II	2016-09-19
K160862	AirStrip RPM	AirStrip Technologies, Inc.	MSX	Class II	2016-09-19
K161940	Guidewire 0.6 Single Use	Fiagon GmbH	PGW	Class II	2016-09-18
K161112	KARL STORZ Flexible Video-Neuro-Endoscope System	Karl Storz Endoscopy-America, Inc.	GWG	Class II	2016-09-17
K162475	mi-eye 2, mi-eye 2 monitor	Trice Medical	HRX	Class II	2016-09-16
K162079	TRILLIUM Oval Head Coil 32	FUJIFILM Healthcare Americas Corporation	MOS	Class II	2016-09-16
K162008	JiveX	Visus Technology Transfer GmbH	LLZ	Class II	2016-09-16
K161946	DoseCHECK	Sun Nuclear Corporation	IYE	Class II	2016-09-16
K161804	LigaSure Retractable L-Hook Laparoscopic Sealer/Divider	Medtronic, Inc.	GEI	Class II	2016-09-16
K161568	Bone Solutions Mixing and Delivery System	Bone Solutions, Inc.	FMF	Class II	2016-09-16
K161489	Syntorr K-wire and Pin System	Syntorr, Inc.	HTY	Class II	2016-09-16
K161162	Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	Ellipse A/S	GEX	Class II	2016-09-16
K160964	Neodent Implant System - Titanium Base for CEREC	JJGC Industria e Comercio de Materiais Dentarios SA	NHA	Class II	2016-09-16
K160735	CATSmart	Fresenius Kabi AB	CAC	Class II	2016-09-16
K160728	NutraStim Hair Laser Helmet	Nutra Luxe MD, LLC	OAP	Class II	2016-09-16
K160262	n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,	Straumann USA, LLC	EIH	Class II	2016-09-16
K153733	VORTRAN Manometer	Vortran Medical Technology 1, Inc	CAP	Class II	2016-09-16
K153654	Sentry WEB SmartInterp	Carefusion Germany 234 GmbH	DQK	Class II	2016-09-16
DEN150056	Acclarent Aera Eustachian Tube Balloon Dilation System	Acclarent Inc	PNZ	Class II	2016-09-16
K162110	CORGRIP NG/NI Tube Retention System	Corpak Medsystems, Inc. A Division of Haylard Health	KNT	Class II	2016-09-15
K162053	PhotonBlade	Invuity, Inc.	GEI	Class II	2016-09-15
K162047	LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated	Medtronic, Inc.	GEI	Class II	2016-09-15
K162013	Eusol-C	Al.chi.mi.a. SRL	LYX	Unclassified	2016-09-15
K162012	CARESCAPE Central Station V2	GE Healthcare	DXJ	Class II	2016-09-15
K161630	Provicol QM Plus	Voco GmbH	EMB	Class I	2016-09-15
K161294	Compound W Wart Removal System Dual Power	MedTech Products, Inc.	GEH	Class II	2016-09-15
K161067	Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”	Engineered Tissue Solutions, LLC	QSZ	Unclassified	2016-09-15
K160828	Dentium Implantium & SuperLine Prosthetics	Dentium Co., Ltd.	NHA	Class II	2016-09-15
K160529	Pledgeted COR-SUTURE QUICK LOAD	Lsi Soultions	GAW	Class II	2016-09-15
K160255	HBOTC Muscle and Nerve Stimulator	Hb Medical, Inc.	NUH	Class II	2016-09-15
K153665	Prow Fusion-L	Nlt Spine, Ltd.	MAX	Class II	2016-09-15
K152946	Tempedy	Seiratherm GmbH	NCX	Class II	2016-09-15
K152023	Luminesse Shaded Zirconia SZ	Talladium Inc	EIH	Class II	2016-09-15
K151962	KBL Sunlamp Products (= Device Bundling name)	Kbl AG	LEJ	Class II	2016-09-15
K162329	CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System	Philips Health Care	IYN	Class II	2016-09-14
K162195	TSolution One Cup1 Surgical System	Think Surgical Inc.	OLO	Class II	2016-09-14
K162177	dS FootAnkle I6CH 1.5T Coil	Invivo Corporation	MOS	Class II	2016-09-14
K162172	EBit Series Diagnostic Ultrasound System	Chison Medical Imaging Co., Ltd.	IYN	Class II	2016-09-14
K161818	GEM Premier 3000	Instrumentation Laboratory Co.	CGA	Class II	2016-09-14
K161658	Anexa Wound Flush, Sterile Water & Sterile Normal Saline	Anexa Biomedical, Inc.	FRO	Unclassified	2016-09-14
K161384	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable	Shockwave Medical, Inc.	PPN	Class II	2016-09-14
K161081	SeaSpine Shoreline ACS - Anterior Cervical Standalone System	SeaSpine Orthopedics Corporation	OVE	Class II	2016-09-14
K160784	CAM Titanium Blanks	Altatec GmbH	NHA	Class II	2016-09-14