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 362 of 3528

510(k) clearances, page 362 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202166	Senhance Surgical System	Asensus Surgical, Inc.	NAY	Class II	2021-03-02
K202113	Ceragem Automatic Thermal Massager, Model CGM-MB-1901	Ceragem Co., Ltd.	JFB	Class II	2021-03-02
K201965	SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2021-03-02
K201852	Surgical Mask-Model Number: Ear Loop, Flat-Pleated	HuiZhou Foryou Medical Devices Co., Ltd.	FXX	Class II	2021-03-02
K201422	Arisure Closed System Drug Transfer Device (CSTD)	Yukon Medical, LLC	ONB	Class II	2021-03-02
K210550	VALO Grand Corded and Accessory Lenses	Ultradent Products Inc.	EBZ	Class II	2021-03-01
K210271	NuVasive Modulus ALIF System	Nu Vasive, Incorporated	OVD	Class II	2021-03-01
K203358	Solitaire X Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	POL	Class II	2021-03-01
K203275	Recon Support Catheter	C.R. Bard Inc	DQY	Class II	2021-03-01
K202776	Fingertip pulse oximeter	Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.	DQA	Class II	2021-03-01
K202743	Med-Link Temp-pulse Oximeter	Shenzhen Med-Link Electronics Tech Co.,Ltd	DQA	Class II	2021-03-01
K202678	OMNI Surgical System	Sight Sciences, Inc.	MRH	Class II	2021-03-01
K202402	Nitrile Examination Gloves (Blue, Violet Blue, White)	Jiangsu Tianshuo Medical Products Co., Ltd.	LZA	Class I	2021-03-01
K202037	imani i2	Imani Co.	HGX	Class II	2021-03-01
K201927	Getinge GSS610N Series Steam Sterilizer	Maquet Cardiovascular Us Sales, LLC	FLE	Class II	2021-03-01
K201533	Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes	Avinent Implant System S.L.U.	KCT	Class II	2021-03-01
DEN200022	Analytic for Hemodynamic Instability (AHI)	Fifth Eye, Inc.	QNV	Class II	2021-03-01
K201644	QardioCore	Qardio, Inc.	DSH	Class II	2021-02-28
K210323	Indigo Aspiration System - Lightning Aspiration Tubing	Penumbra Inc.	QEW	Class II	2021-02-26
K210268	LTJ Screws and Washer	Azurmeds, Inc.	HWC	Class II	2021-02-26
K210033	Laser Treatment System, Model: NYX and Grace	Canadian Pioneer Medical Technology Corporation	GEX	Class II	2021-02-26
K203819	T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System	Stryker Corp.	HSB	Class II	2021-02-26
K203651	Cuptimize	Cuptimize, Inc.	LLZ	Class II	2021-02-26
K203510	IPL Hair removal	Shenzhen Weikai Technology Co.,Ltd	OHT	Class II	2021-02-26
K203439	Disposable Vinyl Examination Gloves	Shandong Zhushi Pharmaceutical Group Co., Ltd	LYZ	Class I	2021-02-26
K203182	SubtleMR	Subtle Medical Inc	LLZ	Class II	2021-02-26
K203020	Spectral CT	Philips Medical Systems Nederland B.V.	JAK	Class II	2021-02-26
K202956	Erisma LP Navigated Instruments	Clariance-SAS	OLO	Class II	2021-02-26
K202702	FLARE Single-Use Surgical Laser Fiber	Realton (Suzhou) Medical Technology Co., Ltd.	GEX	Class II	2021-02-26
K202549	Solax Electric Scooter (Model: S202261B)	Dongguan Prestige Sporting Goods Co., Ltd.	INI	Class II	2021-02-26
K202167	Brite Tip Radianz Guiding Sheath	Cordis US Corp.	DYB	Class II	2021-02-26
K202111	Medical infrared forehead thermometer	Hunan Honggao Electronic Technolofy Co., Ltd.	FLL	Class II	2021-02-26
K202045	imani i1	Imani Co.	HGX	Class II	2021-02-26
K201968	SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2021-02-26
K201967	SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2021-02-26
K201387	Ultrafast, Ultrafast Plus, Ultrafast Lite	Dentlight Inc.	NVK	Class II	2021-02-26
K201316	Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)	Suzhou Peaksonic Medical Technology Co., Ltd.	IYO	Class II	2021-02-26
K201104	AsoAligner	Aso International Manila, Inc.	NXC	Class II	2021-02-26
K200567	ASI Plethysmogrpah Analyzer	Arterial Stiffness, Inc.	JOM	Class II	2021-02-26
K173738	Archworx	Utah Medical Products and Services	NXC	Class II	2021-02-26
DEN200017	Q-Collar	Q30 Sports Science, LLC	QNX	Class II	2021-02-26
DEN190022	Hominis Surgical System	Momentis Surgical Ltd.	QNM	Class II	2021-02-26
K210230	Phenom Catheters	Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular	DQY	Class II	2021-02-25
K203665	STOP U Model UXV Device	Pollogen Ltd	PAY	Class II	2021-02-25
K203578	OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System	Perimeter Medical Imaging AI, Inc.	NQQ	Class II	2021-02-25
K203524	Surgical Masks	Bain Medical Equipment(guangzhou) Co., Ltd.	FXX	Class II	2021-02-25
K203477	Classic	Orthoapnea S.L.	LRK	Class II	2021-02-25
K203332	Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C	Hetaida Technology Co., Ltd.	FLL	Class II	2021-02-25
K203247	iFuse-TORQ™ Implant System	SI-Bone, Inc.	OUR	Class II	2021-02-25
K202990	NinesMeasure	Nines, Inc.	LLZ	Class II	2021-02-25