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 341 of 3528

510(k) clearances, page 341 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210011	JS Dental Lab Mouth Guard	Ampower Dental Laboratories, LLC	MQC	Unclassified	2021-07-16
K203435	Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System	Nihon Kohden Corp.	MHX	Class II	2021-07-16
K203108	Ignite Stemless Anatomic Shoulder System	Ignite Orthopedics, LLC	PKC	Class II	2021-07-16
K201473	ExoAtlet-II	Exoatlet Asia Co., Ltd.	PHL	Class II	2021-07-16
K193397	ADVIA Centaur® Digoxin assay	Siemens Healthcare Diagnostics Inc.	KXT	Class II	2021-07-16
K211933	EleVation Breast Biopsy System	Bard Peripheral Vascular Inc	KNW	Class II	2021-07-15
K211547	Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)	Edma Group, LLC	LZA	Class I	2021-07-15
K211514	Longeviti PorousFit implant	Longeviti Neuro Solutions	KKY	Class II	2021-07-15
K211042	Disposable Procedural Ear-loop Face Mask	Changzhou DSB Medical Co., Ltd	FXX	Class II	2021-07-15
K210750	Acumed Clavicle Hook Plating System	Acumed LLC	HRS	Class II	2021-07-15
K210431	ReCross	IMDS Operations B.V.	DQY	Class II	2021-07-15
K202846	Tera Harz	Graphy Inc.	EBF	Class II	2021-07-15
K202638	Pain Therapy Device	Guangzhou Xinbo Electronic Co., Ltd	NGX	Class II	2021-07-15
K201328	Dexcom G6 Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	QBJ	Class II	2021-07-15
K201100	Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	DWF	Class II	2021-07-15
K200096	Crosstex VH2O2 Chemical Indicators	Crosstex International, Inc. (A Cantel Medical Company)	JOJ	Class II	2021-07-15
K211866	Bencox THR System	Corentec Co., Ltd.	LPH	Class II	2021-07-14
K203728	Darwin	Luvo Medical Technologies, Inc.	GEX	Class II	2021-07-14
K203509	Smart Finder	IMS GIOTTO S.p.A.	IZH	Class II	2021-07-14
K203496	Nexo-Gide Bilayer Collagen Membrane	Geistlich Pharma AG	FTM	Class II	2021-07-14
K203115	ARVIS Surgical Navigation System	Insight Medical Systems, Inc	OLO	Class II	2021-07-14
K203023	Pisces Spinal System	Ortho Development Corp.	NKB	Class II	2021-07-14
K202989	Myopia Master	Oculus Optikgerate GmbH	MXK	Class II	2021-07-14
K202918	OsteoSync™ Ti Dental Mesh	Sites Medical, LLC	JEY	Class II	2021-07-14
K202390	Aduro Light Beauty Mask	Shenzhen Kaiyan Medical CO, Ltd.	OHS	Class II	2021-07-14
K202304	NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)	Nyu Langone Medical Center	PZM	Class II	2021-07-14
K202067	EliA SmDP-S	Phadia AB	LKP	Class II	2021-07-14
K201844	Surgical Face Mask, Surgical Mask	Lear Corporation	FXX	Class II	2021-07-14
K201733	Provident II Hip Stems	Globus Medical, Inc.	LPH	Class II	2021-07-14
K200983	Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine	Ningbo Hesi Electric Co., Ltd.	OHS	Class II	2021-07-14
K193047	N Latex FLC kappa, N Latex FLC lambda	Siemens Healthcare Diagnostics Products Limited	DFH	Class II	2021-07-14
K211938	Physica LMC Knee System	Limacorporate S.p.A.	JWH	Class II	2021-07-13
K211237	UltraTemp Rez II	Ultradent Products Inc.	EMA	Class II	2021-07-13
K203562	Finetest Lite Blood Glucose Monitoring System	OSANG Healthcare CO., Ltd.	NBW	Class II	2021-07-13
K200210	ADVIA Centaur® Total hCG assay	Siemens Healthcare Diagnostics Inc.	DHA	Class II	2021-07-13
K192739	Electric Wheelchair [Models: JRWD6010/JRWD6012]	Jerry Medical Instrument (Shanghai) Co., Ltd.	ITI	Class II	2021-07-13
K211506	PowerLook Density Assessment V4.0	iCAD, Inc.	QIH	Class II	2021-07-12
K211495	Eos Pmp	Corcym Inc.	DTZ	Class II	2021-07-12
K211491	RadiForce RX370	Eizo Corporation	PGY	Class II	2021-07-12
K211113	Zavation Spinal System	Zavation Medical Products, LLC	NKB	Class II	2021-07-12
K210776	Nitrile Examination Gloves	5r Med Instruments (Chengdu) Co., Ltd.	LZA	Class I	2021-07-12
K210723	Nitrile Patient Examination Glove	Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.	LZA	Class I	2021-07-12
K210717	Bone Screws dia. 5,0 mm	Lima Corporate S.p.A.	PHX	Class II	2021-07-12
K210492	InMode RF Pro System	Inmode MD, Ltd.	GEI	Class II	2021-07-12
K210386	Magneto Nasal Mask	Respironics, Inc.	BZD	Class II	2021-07-12
K210244	Disposable Medical Face Mask	Suzhou Bolisi Medical Technology Co., Ltd.	FXX	Class II	2021-07-12
K203556	Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables	Medtronic, Inc.	DSA	Class II	2021-07-12
DEN200039	InSpace Subacromial Tissue Spacer System	Ortho-Space Ltd.	QPQ	Class II	2021-07-12
K210578	Medical Nitrile Examination Gloves (Power free, Blue)	Jiangxi Hongda Medical Equipment Group Ltd.	LZA	Class I	2021-07-10
K211574	Extreme X8	Magic Mobility	ITI	Class II	2021-07-09