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 369 of 3528

510(k) clearances, page 369 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K203308	Ali Interbody Fusion System	Raed M. Ali, M.D., Inc.	MAX	Class II	2021-01-15
K203270	IMMULITE/IMMULITE® 1000 Cortisol	Siemens Healthcare Diagnostics Products Limited	CGR	Class II	2021-01-15
K203209	AirPhysio Positive Expiratory Pressure (PEP) Device	Airphysio Pty, Ltd.	BYI	Class II	2021-01-15
K203142	Veuron-Brain-pAb	Heuron Co., Ltd.	LLZ	Class II	2021-01-15
K202847	AccuBrain	Brainnow Medical Technology Limited	LLZ	Class II	2021-01-15
K202826	IMMULITE® 2000 Cortisol	Siemens Healthcare Diagnostics Products Limited	CGR	Class II	2021-01-15
K202767	Vantage Orian 1.5T, MRT-1550, V6.0	Canon Medical Systems Corporation	LNH	Class II	2021-01-15
K202653	Gymform Total ABS	Well Brain International, Ltd.	NGX	Class II	2021-01-15
K202141	Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set	Argon Medical Devices, Inc	DYB	Class II	2021-01-15
K202107	Medical Protective Mask	Guangdong Kingfa Sci.&tech.co.,Ltd.	FXX	Class II	2021-01-15
K201897	Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525	Richard Wolf Medical Instruments Corp.	FGB	Class II	2021-01-15
K201650	VMCore Biopsy Needle	Uro-1, Inc.	KNW	Class II	2021-01-15
K201582	Non-contact Electronic Forehead Infrared Thermometer	Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.	FLL	Class II	2021-01-15
K201579	Infrared Thermometer	Shenzhen Xunwei Industrial Co., Ltd.	FLL	Class II	2021-01-15
K201085	NeVa PV Thrombectomy Device	Vesalio	QEW	Class II	2021-01-15
K193608	EBERLE Shaver System C3 and Accessories	Eberle GmbH & Co. KG	HRX	Class II	2021-01-15
K193271	uAI EasyTriage-Rib	Shanghai United Imaging Intelligence Co., Ltd.	QFM	Class II	2021-01-15
K203669	Mobius3D	Varian Medical Systems, Inc.	IYE	Class II	2021-01-14
K203241	OmniGuide BeamPath OTO-U Fiber	Omni-Guide Holdings, Inc.	GEX	Class II	2021-01-14
K202769	VELYS™ Robotic-Assisted Solution	Depuy Ireland UC	OLO	Class II	2021-01-14
K202700	ART-Plan	Therapanacea	QKB	Class II	2021-01-14
K202694	Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)	Vycor Medical, Inc.	GZT	Class II	2021-01-14
K202333	Lockado Repositionable Hemostasis Clip	Micro-Tech (Nanjing) Co., Ltd.	PKL	Class II	2021-01-14
K202104	BioGuard EUS Air/Water and Suction Valves	STERIS Corporation	ODC	Class II	2021-01-14
K202019	Maven Patient-Specific Instrumentation	Paragon 28	HSN	Class II	2021-01-14
K201922	Trophikos Vaginal Moisturizer	Trophikos, LLC	NUC	Class II	2021-01-14
K201719	Vital Sleep	The Snore Reliever Company	LRK	Class II	2021-01-14
K200702	EasyPath RF Introducer Sheath	Broncus Medical Inc	EOQ	Class II	2021-01-14
K203671	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	Medacta International SA	OUR	Class II	2021-01-13
K203639	StealthStation Cranial Software v1.3.2	Medtronic Navigation, Inc	HAW	Class II	2021-01-13
K203105	Inion CompressOn Screw	Inion Oy	HWC	Class II	2021-01-13
K202314	Procedure face mask (Model: KKF-2A)	Han Zhaoqing Sporting Goods Company Limited	FXX	Class II	2021-01-13
K201700	BEGO Semados® RS/RSX Implant System	Bego Implant Systems GmbH & Co. KG	DZE	Class II	2021-01-13
K201014	MyOnyx System	Thought Technology Ltd.	KPI	Class II	2021-01-13
K200609	ENTity WiFi Video Nasopharyngoscope System	Optim LLC	EOB	Class II	2021-01-13
K192933	Polyisoprene Powder Free, Black Colour Surgical Gloves	Emerson & Co. S.r.l.	KGO	Class I	2021-01-13
K203658	Micro C Medical Imaging System, M01	Oxos Medical Inc	IZL	Class II	2021-01-12
K203526	C Scope Visualization System	Cit Ortho	HRX	Class II	2021-01-12
K203280	Hepatica v1 (Hepatica v1.0.0)	Perspectum Ltd.	LNH	Class II	2021-01-12
K203201	NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System	Nu Vasive, Incorporated	MAX	Class II	2021-01-12
K203129	NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System	Precision Spine, Inc.	OVE	Class II	2021-01-12
K202843	Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)	B.j.zh.f.panther Medical Equipment Co.,Ltd	FXX	Class II	2021-01-12
K201836	Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i	Canon Medical Systems Corporation	JAK	Class II	2021-01-12
K201625	Disposable Medical Surgical Mask	Tianjin Saiyuan Technology Co., Ltd.	FXX	Class II	2021-01-12
K203397	Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm	Biopsybell S.r.l.	KNW	Class II	2021-01-11
K203231	Switched Internal Paddles	Philips North America LLC	LDD	Class II	2021-01-11
K202577	Medical Surgical Mask-Model MP002-5, MP002-6	Jiangmen Sure&Me Medical Product Co., Ltd.	FXX	Class II	2021-01-11
K202505	GetSet Surgical GoPLF! Posterior Lateral Fusion System	Getset Surgical S.A.	NKB	Class II	2021-01-11
K201471	M-Vizion Femoral Revision System Extension	Medacta International SA	LZO	Class II	2021-01-11
K201241	Striate+™	Orthocell Limited	NPL	Class II	2021-01-11