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FDA 510(k)

Intraosseous Infusion Needles

K-Number: K250724 · 2025-07-30

ApplicantSpectrum Vascular
Decision Date2025-07-30
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intraosseous Infusion Needles is a medical device manufactured by Spectrum Vascular. It received FDA 510(k) clearance on 2025-07-30 under approval number K250724. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraosseous Infusion Needles?

Intraosseous Infusion Needles is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Spectrum Vascular. The 510(k) number is K250724.

When was Intraosseous Infusion Needles approved by the FDA?

Intraosseous Infusion Needles received FDA 510(k) clearance on 2025-07-30, under approval number K250724.

What company makes Intraosseous Infusion Needles?

Intraosseous Infusion Needles is manufactured by Spectrum Vascular.

What is the FDA product code for Intraosseous Infusion Needles?

The FDA product code for Intraosseous Infusion Needles is FMI.

Related Clinical Trials

NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

Other Devices by Spectrum Vascular

K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology K254278Arterial Pressure Monitoring Set/Tray

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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