FDA.report

510(k) K250724

Device
Intraosseous Infusion Needles
Applicant
Spectrum Vascular
510(k) number
K250724
Product code
FMI
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-30
Date received
2025-03-10
Regulation
880.5570
Classification name
Needle, Hypodermic, Single Lumen
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sharon Klugewicz
Address
50 Main St. Suite 1000 White Plains NY US 10606 10606

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FMI

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K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V.2025-04-04
K250658SureFine Pen NeedleShina Med Corporation2025-04-03
K243806Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.2025-01-10
K242741ACE CannulaAce Medical Industry Co., Ltd.2025-01-08