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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 722 of 3530

510(k) clearances, page 722 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K143313	NxStage Therapeutic Plasma Exchange (TPE) Cartridge	NxStage Medical Inc	KDI	Class II	2015-03-20
K143279	LnK Anterior Cervical Plate System	L&K Biomed Co.,Ltd.	KWQ	Class II	2015-03-20
K143211	myVision Track Model 005	Vital Art and Science Incorporated	HOQ	Class I	2015-03-20
K143158	Xenco Medical Lumbar Interbody System	Xenco Medical LLC	MAX	Class II	2015-03-20
K143128	mDIXON XD	Philips Medical Systems Nederland B.V.	LNH	Class II	2015-03-20
K143010	LENSAR Laser System - fs 3D	LENSAR, Inc	OOE	Class II	2015-03-20
K142959	Vyntus Walk	Carefusion Germany 234 GmbH	DQA	Class II	2015-03-20
K142778	ARROW Reverse Shoulder long keel and short keel glenoid base	Fournitures Hospitalieres Industrie	PHX	Class II	2015-03-20
K142769	Fetal Doppler	Icare Newlife Technologies, Inc.	HEK	Class II	2015-03-20
K142711	ONFLEX Mesh	C.R. Bard Inc	FTL	Class II	2015-03-20
K142561	LM-9300 ELMA Lithotripter	Lite-Med, Inc.	LNS	Class II	2015-03-20
K142545	SonoFlow Sonohysterography and Sonohysterosalpingography Device	Crossbay Medical	LKF	Class II	2015-03-20
K142531	F1-Modular Pedicle Screw System	Degen Medical	NKB	Class II	2015-03-20
K142344	DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System	Izi Medical Products LLC	HAW	Class II	2015-03-20
K142332	Bt-400	Bio-Med USA, Inc.	LBI	Class II	2015-03-20
K142174	Biomate Dental Implant System	Biomate Medical Devices Technology Co., Ltd.	DZE	Class II	2015-03-20
K141493	Proximal Humerus Plating System	Miami Device Solutions, LLC	HRS	Class II	2015-03-20
K141460	Finapres Nova Noninvasive Hemodynamic Monitor	Finapres Medical Systems B.V.	DXN	Class II	2015-03-20
K140356	Summed High Pressure Line	Sunny Medical Device (Shenzhen) Co., Ltd.	DQO	Class II	2015-03-20
DEN130047	Prolong	Ergon Medical, Ltd.	PIA	Class II	2015-03-20
K150448	NMI PICC III and NMI PICC IV	Boston Scientific Corporation	LJS	Class II	2015-03-19
K150003	Aquilion LB, TSX-201A/3, V6.0	Toshibamedical Systems Corporation	JAK	Class II	2015-03-19
K143717	Treace Medical Concepts(TMC) Plating System	Treace Medical Concepts, Inc.	HRS	Class II	2015-03-19
K143546	Imbibe Aspirating XIA Taps	Stryker Corp.	KNW	Class II	2015-03-19
K143503	BioMonitor	BIOTRONIK AG	MXD	Class II	2015-03-19
K143463	IS4/DF4 Port Plug	Oscor Inc.	DTD	Class II	2015-03-19
K142337	Blackford Analysis Registration Product Family	Blackford Analysis Ltd	LLZ	Class II	2015-03-19
K141042	Mcare Pf Powder Free Latex Examination High Risk Gloves	Mercator Medical (Thailand) Ltd.	LYY	Class I	2015-03-19
K143703	NICAL SMART MICRO CR system for intraoral dental images	Nical SpA	MUH	Class II	2015-03-18
K143651	Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack	DiaSorin Molecular LLC	PGX	Class II	2015-03-18
K143601	U-Lite	Sonoscanner SARL	IYN	Class II	2015-03-18
K143580	PeriCoach	Analytica, Ltd.	HIR	Class II	2015-03-18
K143218	Penumbra Smart Coil	Penumbra Inc.	HCG	Class II	2015-03-18
K142992	TULIP Natural Rubber Latex Surgeon's Glove (Powdered)	Shanghai Jinxiang Latex Products Co., Ltd.	KGO	Class I	2015-03-18
K142886	DMRC Self-Cure Bracket Adhesive One Step and Primer	Danville Materials, Inc.	DYH	Class II	2015-03-18
K142001	Syntec Wetali Orthodontic Mini Screws	Syntec Scientific Corporation - Taipei Office	OAT	Class II	2015-03-18
K133788	Cook Holmium Laser Fiber	Cook Incorporated	GEX	Class II	2015-03-18
K143663	MiroCam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2015-03-17
K143329	AmpliVue Trichomonas Assay	Ortho-Clinical Diagnostics, Inc.	OUY	Class II	2015-03-17
K143216	Assurance Alar / Nasal SpO2 Sensor	Xhale, Inc.	DQA	Class II	2015-03-17
K143184	Evolve UniPolar Head	Signature Orthopaedics Pty Limited	KWL	Class II	2015-03-17
K150390	Nautilus Spinal System	Life Spine	NKB	Class II	2015-03-16
K150225	NovaGold High Performance Guidewire	Neometrics, Inc.	OCY	Class II	2015-03-16
K150180	InTone	Incontrol Medical, LLC	KPI	Class II	2015-03-16
K150030	Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor	Fukuda Denshi USA, Inc.	MHX	Class II	2015-03-16
K142988	Sleepware G3	Respironics, Inc.	OLZ	Class II	2015-03-16
K141929	Accu-Chek Connect Diabetes Management App	Roche Diagnostics GmbH	NDC	Class II	2015-03-16
K141595	O-Two E700,o-Two E600,o-Two E500	O-Two Medical Technologies, Inc.	BTL	Class II	2015-03-16
K141455	Easydrill Autostop Cranial Perforator	Micromar Ind. Com., Ltd.	HBF	Class II	2015-03-16
K141164	Artemis Light Engine	Quest Medical Imaging	NTN	Class II	2015-03-16