Cleared Traditional

K243581 - K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

K243581 is an FDA 510(k) clearance for K-Pack Enhance Needle (KH-2713RBBTC and..., manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K243581 · Terumo Europe N.V. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
141d
Days
Class 2
Risk

K243581 is an FDA 510(k) clearance for the K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on April 4, 2025 after a review of 141 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 Terumo Europe N.V. devices

FDA 510(k) Submission Details - K243581

510(k) Number K243581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2024
Decision Date April 04, 2025
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 454
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