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 2026-10-12, 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 267 of 3528

510(k) clearances, page 267 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222078	Arthrex SoftStitch	Arthrex GmbH	GAT	Class II	2022-09-14
K221843	GEM Biover Microvascular Clamps	SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.)	DXC	Class II	2022-09-14
K221797	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device	Varian Medical Systems, Inc.	JAQ	Class II	2022-09-14
K221761	Solea	Convergent Dental	NVK	Class II	2022-09-14
K221707	SafeSept® Transseptal Guidewire (SS-140)	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2022-09-14
K220990	Qorda QD1	Winix, Inc.	FRF	Class II	2022-09-14
K220979	SprintRay Denture Base	Sprintray Inc.	EBI	Class II	2022-09-14
K220978	TSX Implants	ZimVie US Corp LLC	DZE	Class II	2022-09-14
K220418	Tornier Perform Humeral System – Stemless	TORNIER Inc.	PKC	Class II	2022-09-14
K213854	SavvyWire	Opsens Inc.	DQX	Class II	2022-09-14
K213293	V-Hepes Plus	Vitromed Langenfeld	MQL	Class II	2022-09-14
K212618	iRelieve Microcurrent Pain Relief System	Fast Track Technologies, Inc.	GZJ	Class II	2022-09-14
K201049	Finder G6pd	Baebies Inc.	JBF	Class II	2022-09-14
K221748	Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves	Guilin HBM Health Protections, Inc.	KGO	Class I	2022-09-13
K221733	MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2022-09-13
K221425	Primary Relief	Dyansys, Inc.	NHI	Class II	2022-09-13
K221417	CLAROX plus (Model: VX-100)	Vsi Co., Ltd.	IZL	Class II	2022-09-13
K221140	P20 Elite Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2022-09-13
K221092	Transcutaneous Electrical Nerve Stimulator Model: ST-304	Shenzhen Future Electronic Co.,Ltd	NUH	Class II	2022-09-13
K220953	ChoiceSpine TigerShark™ M, Modular Interbody System	Choice Spine LLC	MAX	Class II	2022-09-13
K220239	Solid State X-ray Imager(Model: FXRD-4386WB)	Vieworks Co., Ltd.	MQB	Class II	2022-09-13
K214035	LAITEST Medical Face Mask	R&R Medical Corporation Ltd.	FXX	Class II	2022-09-13
K213770	SP-CL Hip Stem and LCU Hip System	Waldemar Link GmbH & Co. KG	LZO	Class II	2022-09-13
K213575	Female IC (Not Finalized)	Hollister Incorporated	EZD	Class II	2022-09-13
K212147	Simplexa COVID-19 Direct	DiaSorin Molecular LLC	QQX	Class II	2022-09-13
K210929	MagiCath II	Woo Young Medical Co., Ltd.	FOZ	Class II	2022-09-13
K222512	Integrity-SI Fusion System	OsteoCentric Technologies,Inc	OUR	Class II	2022-09-12
K221568	KOLO Evolution XHD Series Ultrasound Diagnostic System	Kolo Medical (Suzhou) Co., Ltd.	IYN	Class II	2022-09-12
K221533	Plasma Shield	Plasmatica	GCJ	Class II	2022-09-12
K221456	Rapid ICH	Ischemaview, Inc.	QAS	Class II	2022-09-12
K221450	Phosphoric Acid Etching Gel	Rizhao Huge Biomaterials Company, Ltd.	KLE	Class II	2022-09-12
K220986	Aquilion Precision (TSX-304A/4) V10.10 with AiCE	Canon Medical Systems Corporation	JAK	Class II	2022-09-12
K220084	Infrared Forehead Thermometer	Qingdao Yasee Medical Device Co.,Ltd.	FLL	Class II	2022-09-12
K214024	SOFIA 88 Catheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2022-09-12
K222723	AMBARINO High-Class	Creamed GmbH & Co. Produktions- und Handels KG	EBF	Class II	2022-09-09
K222440	Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays	STERIS Corporation	FRG	Class II	2022-09-09
K222429	Ellusa Reusable Bipolar Cable	Ellusa, LLC	GEI	Class II	2022-09-09
K222093	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2022-09-09
K221388	NuVasive Reline Cervical System	Nu Vasive, Incorporated	NKG	Class II	2022-09-09
K221354	Arthrex SutureTape	Arthrex GmbH	GAT	Class II	2022-09-09
K220944	PointCore Surgical Mask	Pointcore, Inc.	FXX	Class II	2022-09-09
K220859	Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)	Careglove Global Sdn Bhd	LZA	Class I	2022-09-09
K220659	AUTOBAHN(R) EVO Femoral Nails	Globus Medical, Inc.	HSB	Class II	2022-09-09
K220002	Dexus Prosthetics System (Model: MSL1, MSR1)	Zhejiang Qiangnao Technology Co.,Ltd	GXY	Class II	2022-09-09
K214028	MICOR Lens Fragmentation System	Carl Zeiss Meditec Cataract Technology Inc	HQC	Class II	2022-09-09
K213244	Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)	Prevest Denpro Limited	ELW	Class II	2022-09-09
K222425	Ellusa Reusable Neutral Plates	Ellusa, LLC	GEI	Class II	2022-09-08
K222409	CAPTIVATE® Compression Screws	Globus Medical, Inc.	HWC	Class II	2022-09-08
K222076	EFAI ChestSuite XR Pleural Effusion Assessment System	Ever Fortune.Ai, Co., Ltd.	QFM	Class II	2022-09-08
K222020	HD-550 Video Endoscope System	Sonoscape Medical Corp.	NWB	Class II	2022-09-08