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 549 of 3529

510(k) clearances, page 549 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173469	16ch T/R Hand Wrist Coil	Quality Electrodynamics	MOS	Class II	2018-01-09
K173263	Xpert Carba-R	Cepheid	POC	Class II	2018-01-09
K173021	Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems	Supersonic Imagine	IYN	Class II	2018-01-09
K172662	reVive Perioral	LED Technologies, Inc.	OHS	Class II	2018-01-09
K172212	MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™	CTL Medical Corporation	ODP	Class II	2018-01-09
K172193	Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules	Alma Lasers Ltd.	GEX	Class II	2018-01-09
K172183	Guided Growth Plate System Plus	Orthofix SRL	OBT	Class II	2018-01-09
K171775	Theradome LH80 PRO	Theradome, Inc.	OAP	Class II	2018-01-09
K171295	ULab Systems Treatment Planning Software	uLab Systems, Inc	PNN	Class II	2018-01-09
K163027	Ultra/Phonic Free Conductivity Gel	Pharmaceutical Innovations, Inc.	MUI	Class II	2018-01-09
K163026	Ultra/Phonic Scanning Gel	Pharmaceutical Innovations, Inc.	MUI	Class II	2018-01-09
K173759	Thermage CPT System and Accessories	Solta Medical, Inc.	GEI	Class II	2018-01-08
K173471	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2018-01-08
K173293	EVOS Small Fragment Upper Extremity Plates	Smith & Nephew, Inc.	HRS	Class II	2018-01-08
K173159	Cervical Spinal Truss System (CSTS) Interbody Fusion Device	4WEB Inc.	ODP	Class II	2018-01-08
K173085	invendoscopy E210 System	Invendo Medical GmbH	FDF	Class II	2018-01-08
K172942	Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein	Beta Healthcare Products Pvt., Ltd.	KGO	Class I	2018-01-08
K172858	PreOp	Epilog	OLX	Class II	2018-01-08
K171328	cNeuro cMRI	Combinostics	LLZ	Class II	2018-01-08
K163024	Ultra/Phonic Conductivity Gel	Pharmaceutical Innovations, Inc.	MUI	Class II	2018-01-08
K163023	Other-Sonic Transmission Gel	Pharmaceutical Innovations, Inc.	MUI	Class II	2018-01-08
K173650	AquaShield System CO2- Fujifilm	United States Endoscopy Group, Inc.	FEQ	Class II	2018-01-05
K173456	ViewPoint 6	GE Medical Systems Ultrasound and Primary	LLZ	Class II	2018-01-05
K173278	ToggleLoc System	Zimmer GmbH	MBI	Class II	2018-01-05
K173252	BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)	Becton Dickinson & Co	LON	Class II	2018-01-05
K172968	Hair Up	Y&j Bio Co., Ltd.	OAP	Class II	2018-01-05
K172518	Spineology Navigation Instruments	Spineology, Inc.	OLO	Class II	2018-01-05
K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	Pulpdent Corporation	EBC	Class II	2018-01-05
K172029	EnsoETM	Attune Medical	PLA	Class II	2018-01-05
K171948	Roadrunner Extra Support Wire Guide	Cook Incorporated	DQX	Class II	2018-01-05
K171860	Sureclear aligners	Emergo Global Consulting, LLC	NXC	Class II	2018-01-05
K171721	Electrodes with silver conductive	Shenzhen Konmed Technology Co., Ltd	GXY	Class II	2018-01-05
K171518	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles	Zhejiang Kindly Medical Devices Co., Ltd.	BSP	Class II	2018-01-05
K171436	STRONG Dental Handpieces	Saeshin Precision Co., Ltd.	EGS	Class I	2018-01-05
K171099	EON Portable Reverse Osmosis Water Purification System	Cantel	FIP	Class II	2018-01-05
K172702	Tec 820, Tec 850	GE Healthcare	CAD	Class II	2018-01-04
K172701	Bio-C Sealer	Angelus Industria de Produtos Odontologicos S/A	KIF	Class II	2018-01-04
K172456	Bone Screws 6.5mm	Lima Corporate S.p.A.	LPH	Class II	2018-01-04
K171836	EarlySense Bed Sensing Unit	Earlysense, Ltd.	BZQ	Class II	2018-01-04
K171819	Attain Assist CS Access Catheter	Creganna Medical Also Doing Business AS Ceganna Tactx Medica	DQY	Class II	2018-01-04
K171410	ePatch	Braemar Manufacturing, LLC	DSH	Class II	2018-01-04
K171372	Alians Elbow Locking Plating System	Newclip Technics	HRS	Class II	2018-01-04
K171235	OmniCap	Respirion, Inc.	CCK	Class II	2018-01-04
K171113	LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module	LiNA Medical Inc	HIH	Class II	2018-01-04
K171056	WAVE Clinical Platform	Excel Medical Electronics, LLC	MWI	Class II	2018-01-04
K173702	Juliet Ti LL	Spineart SA	MAX	Class II	2018-01-03
K173198	Facet Screw Fixation System	CG MedTech Co., Ltd.	MRW	Unclassified	2018-01-03
K172798	Straumann CARES Abutments CoCr	Straumann USA, LLC	NHA	Class II	2018-01-03
K172502	Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate	Biomet Manufacturing Corp	PHX	Class II	2018-01-03
K170924	AirFit F20	ResMed Corp	BZD	Class II	2018-01-03