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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 434 of 3528

510(k) clearances, page 434 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192224	Btl-899	Btl	GEI	Class II	2019-12-05
K191996	BC Reflex Uni Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2019-12-05
K191962	Vitra 2	Quantel Medical	GEX	Class II	2019-12-05
K191864	21Hk512d	LG Electronics.Inc	PGY	Class II	2019-12-05
K191804	TOMi Scope	Photonicare Inc	QJG	Class II	2019-12-05
K191760	PICO 14 Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2019-12-05
K191250	Southern Implants PEEK Abutments	Southern Implants, (Pty.) Ltd.	NHA	Class II	2019-12-05
K191191	Neodent Implant System - Temporary Abutments	JJGC Industria e Comercio de Materiais Dentarios SA	NHA	Class II	2019-12-05
K190660	G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene	Zimmer GmbH	LPH	Class II	2019-12-05
K182758	MCI - CMF System	Mci Medical Concept Innovation Inc.	JEY	Class II	2019-12-05
DEN190016	cobas vivoDx MRSA	Roche Molecular Systems Inc	QIV	Class II	2019-12-05
K193069	AIROS 6 Sequential Compression Device	Airos Medical Inc	JOW	Class II	2019-12-04
K193068	AIROS 8 Sequential Compression Device	Airos Medical Inc	JOW	Class II	2019-12-04
K193020	VenaPro Vascular Therapy System	Innovamed Health, LLC	JOW	Class II	2019-12-04
K192430	Epic 980	Biolase, Inc.	GEX	Class II	2019-12-04
K192348	SICAT Implant V2.0	Sicat GmbH & Co. KG	LLZ	Class II	2019-12-04
K192335	TRACKER Kyphoplasty System	GS Medical Co., Ltd.	NDN	Class II	2019-12-04
K191759	Medline Quick Switch Valve with ENFit Connector	MEDLINE INDUSTRIES, LP - Northfield	PIF	Class II	2019-12-04
K191379	RELiZORB	Alcresta Therapeutics, Inc.	PLQ	Class II	2019-12-04
K191371	MolecuLight i:X	Moleculight Corp	QJF	Class II	2019-12-04
K193160	Glidesheath Slender Tibial Pedal Kit	Terumo Medical Coporation	DYB	Class II	2019-12-03
K193107	TriSalus Infusion System	Trisalus Life Sciences	KRA	Class II	2019-12-03
K193083	M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System	Medacta International SA	OUR	Class II	2019-12-03
K193009	Promisemed Heel Blood Lancet	Promisemed Hangzhou Meditech Co.,Ltd.	FMK	Class II	2019-12-03
K192528	CO2 Laser Therapy System	Shangdong Huamei Technology Co., Ltd.	GEX	Class II	2019-12-03
K192473	Exsomed Wrist Plating System	Exsomed Corp.	HRS	Class II	2019-12-03
K192132	SeaSpine Beachside System	SeaSpine Orthopedics Corporation	MAX	Class II	2019-12-03
K191522	Straumann Modular Cassette	Straumann USA, LLC	KCT	Class II	2019-12-03
K183371	Deka Tiac 1	El..En. Electroic Engineering SpA	PBX	Class II	2019-12-03
K192666	Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet	Promisemed Hangzhou Meditech Co.,Ltd.	FMK	Class II	2019-12-02
K192394	Hi-Fatigue Bone Cement	Osartis GmbH	LOD	Class II	2019-12-02
K192374	Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip	Cardinal Health200, LLC	FXX	Class II	2019-12-02
K192038	Emprint Visualization Application	Medtronic, Inc.	LLZ	Class II	2019-12-02
K191722	Vital Navigation System	Highridge Medical, LLC	OLO	Class II	2019-12-02
K191656	Zipbond	Sdi Ltd.	KLE	Class II	2019-12-02
K191088	Checkme O2 Pulse Oximeter	Shenzhen Viatom Technology Co., Ltd.	DQA	Class II	2019-12-02
K190987	Uroject12 Syringe Lever	Urogen Pharma Ltd.	QBL	Class II	2019-12-02
K190876	mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed	Mercator Medical (Thailand) Ltd.	LZA	Class I	2019-12-02
K190659	Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip	Allwin Medical Devices, Inc.	FAD	Class II	2019-12-02
K190588	Integra TITAN Reverse Shoulder System	Integra LifeSciences Corporation	PHX	Class II	2019-12-02
K190009	Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)	Hong Qiangxing (Shenzhen) Electronics Limited	NUH	Class II	2019-12-02
K183622	NasalCEASE and BleedCEASE	Les Laboratoires Brothier S.A.	QSY	Unclassified	2019-12-02
K182819	Decanting Device	Gcmedica Enterprise Ltd. (Wuxi)	LHI	Class II	2019-12-02
DEN180014	WOUNDCHEK Bacterial Status	Alere Scarborough, Inc.	QFA	Class II	2019-12-02
K193040	Resorbable Mesh Device	SeaSpine Orthopedics Corporation	MQV	Class II	2019-11-30
K193034	AXS Infinity LS Plus Long Sheath	Stryker Corp.	DQY	Class II	2019-11-29
K192782	ASAHI CROSSWALK Peripheral Support Catheter	Asahi Intecc Co., Ltd.	DQY	Class II	2019-11-29
K192365	Shoulder Innovations Total Shoulder System	SHOULDER INNOVATIONS, Inc	KWT	Class II	2019-11-29
K192186	I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph	Neurolign USA, LLC	GWN	Class II	2019-11-29
K192105	Innonix Antiviral Child's Face Mask	Innonix Technologies Limited	OUK	Class II	2019-11-29