Cleared Traditional

K250724 - Intraosseous Infusion Needles

K250724 is an FDA 510(k) clearance for Intraosseous Infusion Needles, manufactured by Spectrum Vascular. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K250724 · Spectrum Vascular · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
142d
Days
Class 2
Risk

K250724 is an FDA 510(k) clearance for the Intraosseous Infusion Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on July 30, 2025 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrum Vascular devices

FDA 510(k) Submission Details - K250724

510(k) Number K250724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date July 30, 2025
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 271
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