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 2026-10-21, 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 545 of 3529

510(k) clearances, page 545 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172105	The Plateau-LO Spacer System	Life Spine	MAX	Class II	2018-02-02
K172005	PICO 7 Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2018-02-02
K171450	Glooko Mobile Insulin Dosing System	Glooko Inc	NDC	Class II	2018-02-02
K171403	OralTox Oral Fluid Drug Test	Premier Biotech, LLC	DJC	Class II	2018-02-02
K171402	KARL STORZ Slim Nasopharyngolaryngoscope	Karl Storz Endoscopy-America, Inc.	EOB	Class II	2018-02-02
K170112	IMD's Lumbar Puncture Needle	International Medical Development, Inc.(Imd)	BSP	Class II	2018-02-02
K180039	ACUSON P600 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2018-02-01
K173957	ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2018-02-01
K173443	AEON Endoscopic Stapler	Lexington Medical, Inc.	GDW	Class II	2018-02-01
K173047	The Solstice OCT System	Life Spine	NKG	Class II	2018-02-01
K172828	Double Medical Cage System	Double Medical Technology Inc.	MAX	Class II	2018-02-01
K172789	Specimen Retrieval Bag	Beijing Hangtian Kadi Technology R&D Institute	GCJ	Class II	2018-02-01
K172509	Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc	OQO	Class II	2018-02-01
K172395	Duatene bilayer mesh	Sofradim Production	FTL	Class II	2018-02-01
K172146	Meristeel	M/s. Meril Endo Surgery Private Limited.	GAQ	Class II	2018-02-01
K171662	Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter	Cook Incorporated	KOD	Class II	2018-02-01
K171629	ABCcolla Bone Graft	Acro Biomedical Co., Ltd.	MQV	Class II	2018-02-01
K171384	Micromed BRAIN QUICK system	MicroMed, LLC	GWQ	Class II	2018-02-01
K171287	Sporview VH202 BI	Spsmedical Supply Corp. A Division of Cantel Medical	FRC	Class II	2018-02-01
K161989	PREMIUM Implant Systems SHELTA Implant Systems	Sweden & Martina Inc	NHA	Class II	2018-02-01
K180010	AtriClip FLEX-V	AtriCure, Inc.	FZP	Class II	2018-01-31
K173601	Merit Syringe	Merit Medical Systems, Inc.	FMF	Class II	2018-01-31
K173530	Indego(R)	Parker Hannifin Corp.	PHL	Class II	2018-01-31
K173088	Vitrea Software Toshiba Package VSTP-001A	Toshibamedical Systems Corporation	LLZ	Class II	2018-01-31
K172845	Symetri Clear	Ormco Corp.	NJM	Class II	2018-01-31
K172643	da Vinci Xi Surgical System; da Vinci X Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2018-01-31
K172567	GORE Molding and Occlusion Balloon Catheter	W. L. Gore & Associates, Inc.	MJN	Class II	2018-01-31
K172240	SPI Dental Implant System	Msi France	DZE	Class II	2018-01-31
K171772	Ecosite Bulk Fill	Dmg USA, Inc.	EBF	Class II	2018-01-31
K171396	ODFS Pace XL	Odstock Medical Ltd	GZI	Class II	2018-01-31
K171297	AR_N Type Implant System	Biotem Co., Ltd.	DZE	Class II	2018-01-31
K173436	Luma Light System	Luma Therapeutics	FTC	Class II	2018-01-30
K173417	Zimmer Persona Personalized Knee System	Zimmer GmbH	MBH	Class II	2018-01-30
K173389	Rex Medical Aspiration Pump	Rex Medical LP	BTA	Class II	2018-01-30
K172159	Getinge GSS67N Series Steam Sterilizer	Maquet Cardiovascular Us Sales, LLC	FLE	Class II	2018-01-30
K171835	Irradiation Aesthetic Device	Chongqing Peninsula Medical Technology Co., Ltd.	OAP	Class II	2018-01-30
K171500	Uro-V Cystoscope	Uroviu Corporation	FAJ	Class II	2018-01-30
K170438	MiroCam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2018-01-30
K173814	DeGen Medical E3 MIS Pedicle Screw System	Degen Medical	NKB	Class II	2018-01-29
K173596	Rusch Intermittent Urethral Catheters	Teleflex Medical	EZC	Class II	2018-01-29
K173285	Joule System	Sciton, Inc.	GEX	Class II	2018-01-29
K163081	40-42mm BiPolar Head and 22mm Femoral Head	Signature Orthopaedics Pty Limited	KWY	Class II	2018-01-29
K173955	Mic-Key* SF Over-the-Wire Stoma Measuring Device	Halyard Health	KNT	Class II	2018-01-26
K173953	uDR 780i	Shanghai United Imaging Healthcare Co., Ltd.	KPR	Class II	2018-01-26
K173932	Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2	Alere Scarborough, Inc.	OCC	Class II	2018-01-26
K173843	illumiflow 148 Laser Cap	Eglobal, LLC	OAP	Class II	2018-01-26
K173709	Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm	Inneuroco, Inc.	DQY	Class II	2018-01-26
K173558	SyMRI	Syntheticmr AB	LNH	Class II	2018-01-26
K173466	Panthera Dental Milled Bars	Panthera Dental Inc	NHA	Class II	2018-01-26
K173430	SeQure® NF and SeQure® Microcatheters	Accurate Medical Therapeutics, Ltd.	DQO	Class II	2018-01-26