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 324 of 3528

510(k) clearances, page 324 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210706	Nitrile Examination Gloves	Niujian Technology Co., Ltd.	LZA	Class I	2021-10-19
K210204	Capsule Vitals Plus Patient Monitoring System	Capsule Technologie SAS	MWI	Class II	2021-10-19
K210124	Synergy Gold (SG) Portable (Models MM011450 and MM011460)	Uzinmedicare Co., Ltd.	HGX	Class II	2021-10-19
K203565	Surgical 3D Mask	Inno Lifecare	FXX	Class II	2021-10-19
K202982	Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)	Winner Medical Co., Ltd.	FRO	Unclassified	2021-10-19
K201773	Picohi	Hironic Co., Ltd.	GEX	Class II	2021-10-19
K192746	MyoWorx TM20	Myoworx, Inc.	IPF	Class II	2021-10-19
K212753	0909Fcb, 1212Fca	Rayence Co., Ltd.	MQB	Class II	2021-10-18
K212632	ClotTriever Thrombectomy System	Inari Medical, Inc.	QEW	Class II	2021-10-18
K212528	Change Healthcare Cardiology	Change Healthcare Israel Ltd.	LLZ	Class II	2021-10-18
K211809	Surgical Gown	Wuhan Dymex Healthcare Co., Ltd.	FYA	Class II	2021-10-18
K211582	LOQTEQ Proximal Humerus Plate 3.5 System	AAP Implantate AG	HRS	Class II	2021-10-18
K211555	Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	MEG	Class II	2021-10-18
K201017	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit	Geneohm Sciences Canada, Inc. (BD Life Sciences)	PQA	Class II	2021-10-18
K193613	Allergen-Specific IgE Assay 12 Allergen Bundle	Canon Medical Diagnostics USA, Inc.	DHB	Class II	2021-10-18
K212967	AxTiHA Stand-Alone ALIF System	Innovasis, Inc	OVD	Class II	2021-10-15
K212959	ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2021-10-15
K212636	CORUS Spinal System-X	Providence Medical Technology, Inc.	HRX	Class II	2021-10-15
K212593	ViaCath, AcQRate Dx Steerable Catheter	Biotronick, Inc.	DRF	Class II	2021-10-15
K212517	Magicore System	Innobiosurg Co., Ltd.	DZE	Class II	2021-10-15
K211992	Ortho MI System	Osteonic Co., Ltd.	OAT	Class II	2021-10-15
K211403	HIVOX OTC Electrical Stimulator, FT610-B	Hivox Biotek Inc.	NUH	Class II	2021-10-15
K211224	RM4 Control Unit	Institut Georges Lopez	KDN	Class II	2021-10-15
K211091	Deka Tiac II	El.en. Electronic Engineering SpA	PBX	Class II	2021-10-15
K210563	Arm Blood Pressure Monitor	Alicn Medical Shenzhen, Inc	DXN	Class II	2021-10-15
K202433	Aqueduct 200 Cervical Dilation Balloon Catheter	Gtimd, LLC	PON	Class II	2021-10-15
K201880	MultiSure GK Link Blood Glucose and Ketone Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2021-10-15
K213002	SCORPION Portal Vein Access Set	Argon Medical Devices, Inc	DYB	Class II	2021-10-14
K212261	StrokeSENS LVO	Circle Neurovascular Imaging, Inc.	QAS	Class II	2021-10-14
K212205	Medical Protective Masks	Qinhuangdao Taizhi Medical Technology Co., Ltd	FXX	Class II	2021-10-14
K211914	Nitrile Patient Examination Gloves	Yingxiang Glove Products Co., Ltd.	LZA	Class I	2021-10-14
K211807	Sapphire NC 24	OrbusNeich Medical (Shenzhen) Co., Ltd.	LOX	Class II	2021-10-14
K211753	Sterile Syringe With Safety Needle	Jiangxi Hongda Medical Equipment Group Ltd.	MEG	Class II	2021-10-14
K211461	Family of Venus RF Systems - Venus Freedom	Venus Concept USA Inc.	PBX	Class II	2021-10-14
K211214	Sterile Hypodermic Needles for Single Use	Azur Medical Company, Inc.	FMI	Class II	2021-10-14
K211147	ALGO 7i	Path Medical GmbH	GWJ	Class II	2021-10-14
K211121	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit	Intera Oncology	PTI	Class II	2021-10-14
K210999	SwiftMR	AIRS Medical Inc.	LLZ	Class II	2021-10-14
K210231	Vittra APS Unique	Dentscare Ltda	EBF	Class II	2021-10-14
K202808	Brainance MD	Advantis Medical Imaging Single Member P.C.	LLZ	Class II	2021-10-14
K202688	AFS Medical Sterile Single-Use Access Port System	Afs Medical Co., Ltd.	OTJ	Class II	2021-10-14
K212908	EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device	Neuravi Limited	NRY	Class II	2021-10-13
K212825	CoreLink Navigation Instruments	Corelink, LLC	OLO	Class II	2021-10-13
K212544	MiniLoad Syringe	Ocuject, LLC	FMF	Class II	2021-10-13
K212014	Medical Nitrile Examination Gloves	Jiangxi Ronglai Medical Technology Co., Ltd.	LZA	Class I	2021-10-13
K211905	UltraCal XS	Ultradent Products Inc.	KIF	Class II	2021-10-13
K211801	SPRINT PNS System	SPR Therapeutics, Inc	NHI	Class II	2021-10-13
K211374	Proclean - Nitrile Powder Free Examination Gloves	Dr.Boo Company Limited	LZA	Class I	2021-10-13
K210116	Video Endoscopy System, 3D Video Endoscopy System	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	HET	Class II	2021-10-13
K212562	Idys-C ZP 3DTi	Clariance, Inc.	OVE	Class II	2021-10-12