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 625 of 3529

510(k) clearances, page 625 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161065	ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator	Surgitools Pty, Ltd.	HEW	Class II	2016-10-27
K160885	HemosIL D-Dimer HS	Instrumentation Laboratory Co.	DAP	Class II	2016-10-27
K160316	SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles	M.D.L. S.r.l.	KNW	Class II	2016-10-27
K160296	SPROTTE SPECIAL NRFit	Pajunk GmbH Medizintechnologie	BSP	Class II	2016-10-27
K160295	SPROTTE NRFit, Quincke NRFit	Pajunk GmbH Medizintechnologie	BSP	Class II	2016-10-27
K160121	CorPath GRX System	Corindus, Inc.	DXX	Class II	2016-10-27
K153332	ETIII SA Fixture System (O3.2mm)	Hiossen, Inc.	DZE	Class II	2016-10-27
K162762	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2016-10-26
K162514	Multichem A1c	Technopath Manufacturing	JJX	Class I	2016-10-26
K162469	CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps	Medos International SARL	GEI	Class II	2016-10-26
K162250	FortiBridge Anterior Cervical Plate System	Nanovis Spine, LLC	KWQ	Class II	2016-10-26
K162138	NuVasive CoRoent Small Ti-C System	Nu Vasive, Incorporated	ODP	Class II	2016-10-26
K161830	Zimmer M/L Taper Hip Prosthesis	Zimmer GmbH	LZO	Class II	2016-10-26
K161393	Reprocessed Orbiter ST Steerable Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2016-10-26
K161351	NanoBone SBX Putty	Artoss, Inc.	MQV	Class II	2016-10-26
K161194	PLEX Elite 9000 SS-OCT	Carl Zeiss Meditec Inc	OBO	Class II	2016-10-26
K160583	REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip	Volcano Corporation	OBJ	Class II	2016-10-26
K162736	Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT	Siemens Medical Solutions USA, Inc.	KPS	Class II	2016-10-25
K162695	truFreeze System	CSA Medical	GEH	Class II	2016-10-25
K162443	PowerPICC Provena Catheters	C.R. Bard Inc	LJS	Class II	2016-10-25
K162386	KATOR Suture Anchor	Kator, LLC	MBI	Class II	2016-10-25
K162370	syngo.via RT Image Suite	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2016-10-25
K162274	Solana Strep Complete Assay	Ortho-Clinical Diagnostics, Inc.	PGX	Class II	2016-10-25
K162145	vRad PACS with Mammography	Virtual Radiologic Corporation	LLZ	Class II	2016-10-25
K162117	Niro-200Nx Dp	Hamamatsu Photonics K.K.	MUD	Class II	2016-10-25
K162080	t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater	Tandem Diabetes Care, Inc.	LZG	Class II	2016-10-25
K162076	chromID MRSA	bioMerieux, Inc.	JSO	Class II	2016-10-25
K161973	G-scan Brio, S-scan	Esaote S.p.A.	LNH	Class II	2016-10-25
K161042	CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack	Kuraray Noritake Dental, Inc.	KLE	Class II	2016-10-25
K160260	Tempo Temporary Pacing Lead	Biotrace Medical, Inc.	LDF	Class II	2016-10-25
K162060	Ahmed Glaucoma Valve	New World Medical, Inc.	KYF	Class II	2016-10-24
K161846	Automatic Arm Bluetooth Blood Pressure Monitor	Truly Instrument Limited	DXN	Class II	2016-10-24
K161720	Standard Clamp	Standard Bariatrics	GCJ	Class II	2016-10-24
K161701	CARTO ENT System	Biosense Webster Inc	PGW	Class II	2016-10-24
K161698	Relieva UltirraNav Sinus Balloon Catheter	Acclarent Inc	LRC	Class I	2016-10-24
K161697	Acclarent NavWire Sinus Navigation Guidewire	Acclarent Inc	PGW	Class II	2016-10-24
K161426	NeoSpan Compression Staple Impant w/instruments	In2bones USA, LLC	JDR	Class II	2016-10-24
K160245	Visco (olifilcon A) soft contact lens	Visco Vision Inc.	LPL	Class II	2016-10-24
K153188	Caremed patient cable and leadwires	Shenzhen Caremed Medical Technology Co.,Ltd.	DSA	Class II	2016-10-24
K151399	Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow	Schutz-Dental GmbH	EBF	Class II	2016-10-24
K162687	Paragon 2	Meridian Medical Systems, LLC	IZL	Class II	2016-10-21
K162635	Distal Radius Plating System	Miami Device Solutions, LLC	HRS	Class II	2016-10-21
K162554	Gentrix Surgical Matrix	ACell, Inc	FTM	Class II	2016-10-21
K162474	Artemis	Eigen	LLZ	Class II	2016-10-21
K162317	Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens	St. Shine Optical Co., Ltd.	LPL	Class II	2016-10-21
K162061	M.U.S.T. Pedicle Screw System	Medacta International SA	NKB	Class II	2016-10-21
K162027	TRAcelet Compression Device	Medtronic, Inc.	DXC	Class II	2016-10-21
K161773	CapsoCam Plus (SV-3) Capsule Endoscope System	CapsoVision, Inc.	NEZ	Class II	2016-10-21
K161555	KARL STORZ NAV1 Electromagnetic Navigation System	Karl Storz Endoscopy-America, Inc.	PGW	Class II	2016-10-21
K161481	Ambient HipVac 50 Wand with Integrated Finger Switches	ArthroCare Corporation	GEI	Class II	2016-10-21