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 359 of 3528

510(k) clearances, page 359 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202081	Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue	Shen Wei (USA), Inc.	LZA	Class I	2021-03-19
K201095	Sovereign America Surgical Face Mask	Homtex, Inc.	FXX	Class II	2021-03-19
K192731	ZIDA Wearable Neuromodulation System	Exodus Innovations	NAM	Class II	2021-03-19
K210584	SDC3 HD Information Management System with Wireless Device Control Capability	Stryker Corp.	GCJ	Class II	2021-03-18
K210551	Persona Revision Knee System	Zimmer GmbH	JWH	Class II	2021-03-18
K210449	Infinity™ OCT System, PASS OCT® Spinal System	Medtronic, Inc.	NKG	Class II	2021-03-18
K210286	Cure 2.0 Anterior Cervical Plate (ACP) System	Meditech Spine, LLC	KWQ	Class II	2021-03-18
K210285	Adaptable Ortho Innovations Intramedullary Nail System	Adaptable Ortho Innovations, LLC	HSB	Class II	2021-03-18
K210041	HySil Plus Impression Materials	OSSTEM Implant Co., Ltd.	ELW	Class II	2021-03-18
K203679	Automatic Registration	Brainlab, Inc.	OLO	Class II	2021-03-18
K203444	BEE HA Cage	Ngmedical GmbH	ODP	Class II	2021-03-18
K203342	CONSTRUX Mini Ti Spacer System	Orthofix SRL	ODP	Class II	2021-03-18
K203186	DYNATAPE Suture	Medos International SARL	GAT	Class II	2021-03-18
K202937	Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702	Ceragem Co., Ltd.	JFB	Class II	2021-03-18
K202773	s-Clean SQ-SL Implant System Mini	Dentis Co.,Ltd	DZE	Class II	2021-03-18
K202482	Y207 Electric Wheelchair	Jiangsu Intco Medical Products Co., Ltd.	ITI	Class II	2021-03-18
K201681	Straumann Immediate Temporary Abutments	Straumann USA, LLC	NHA	Class II	2021-03-18
K201624	Spin Care Disposable Protective Mask	Spintech, Inc.	FXX	Class II	2021-03-18
K200925	Clarus Peel-Away Introducer Sheath	Clarus Medical, LLC	GWG	Class II	2021-03-18
K210450	BBX-PET Scanner	Prescient Imaging, LLC	KPS	Class II	2021-03-17
K203684	Neurosign V4 Intraoperative Nerve Monitor	Magstim Inc.	PDQ	Class II	2021-03-17
K203428	Ziehm Vision RFD	Ziehm Imaging GmbH	JAA	Class II	2021-03-17
K203361	ProLift Wedge Expandable Spacer System	Life Spine	MAX	Class II	2021-03-17
K203083	Magic 360 Power Wheelchair	Magic Mobility	ITI	Class II	2021-03-17
K202082	Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid	Shen Wei (USA), Inc.	LZA	Class I	2021-03-17
DEN200031	BioFire Respiratory Panel 2.1 (RP2.1)	BioFire Diagnostics, LLC	QOF	Class II	2021-03-17
K210487	MIPLNI YK-244 Disposable Surgical Mask	Hunan Yuankang Biological Technology Co., Ltd.	FXX	Class II	2021-03-16
K203252	Multi-unit Abutments for CONELOG	BioHorizons Implant Systems Inc	NHA	Class II	2021-03-16
K202554	Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis	Stryker Sustainability Solutions	NLQ	Unclassified	2021-03-16
K202086	Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors	Shen Wei (USA), Inc.	LZA	Class I	2021-03-16
K201723	F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2021-03-16
K210193	DB-Composite	Dimensional Bioceramics, LLC	MQV	Class II	2021-03-15
K203382	Neodent Implant System-Easy Pack	JJGC Industria e Comercio de Materiais Dentarios SA	DZE	Class II	2021-03-15
K202438	Ensure Single-Use Coagulation Forceps	Micro-Tech (Nanjing) Co., Ltd.	KGE	Class II	2021-03-15
K201924	Single-Use Surgical Mask	Qiqihar Hengxin Medical Supplies, Ltd.	FXX	Class II	2021-03-15
K201698	Medical Surgical Mask	Hangzhou Mycode Bio-Medicine Co., Ltd.	FXX	Class II	2021-03-15
K210526	Medline Cautery Tip Cleaner	MEDLINE INDUSTRIES, LP - Northfield	GEI	Class II	2021-03-12
K210060	CoLink Mfx Implant System	In2bones USA, LLC	HRS	Class II	2021-03-12
K203822	ProFound AI Software V3.0	iCAD, Inc.	QDQ	Class II	2021-03-12
K203775	AIC disposable medical mask	The Aleen International Corporation	FXX	Class II	2021-03-12
K203707	Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603	Shenzhen Zhengkang Technology Co., Ltd.	FLL	Class II	2021-03-12
K203697	BC Reflex Uni Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2021-03-12
K203666	Vinyl Examination Gloves(Yellow)	Lutai Medical Technology Co., Ltd.	LYZ	Class I	2021-03-12
K203250	TaiChiC	Our United Corporation	IWB	Class II	2021-03-12
K203188	Add	H&abyz	MQB	Class II	2021-03-12
K203060	VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control	Advanced Medical Optics, Inc.	HQC	Class II	2021-03-12
K202284	Oncospace	Oncospace, Inc.	MUJ	Class II	2021-03-12
K201617	TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))	Schoelly Fiberoptic, GmbH	HET	Class II	2021-03-12
K201452	Groshong NXT PICC Catheter	C.R. Bard Inc	LJS	Class II	2021-03-12
K201410	VENUS Bracket, ROSE Bracket	Gni Co., Ltd.	NJM	Class II	2021-03-12