Cleared Traditional

Intraosseous Infusion Needles (K250724) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250724 · Spectrum Vascular · General Hospital
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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

Submission Details

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.

Device Classification

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 195
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K250724.
Pen Needle
K252886 · Hh Global Technology, Inc. · Jan 2026
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K250700 · Terumo Corporation · Nov 2025
Profoject™ Disposable Needle
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K250284 · Tsk Laboratory, Japan · Jul 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · Terumo Europe N.V. · Jul 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
K243309 · Terumo Europe N.V. · May 2025