Cleared Traditional

K243581 - K-Pack Enhance Needle (KH-2713RBBTC and...

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

K243581 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF)
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

Submission Details

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.

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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K243581.
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
FROG (Filter Removal of Glass)
K240355 · Carrtech Corp · Apr 2025
SureFine Pen Needle
K250658 · Shina Med Corporation · Apr 2025
Safety Winged Blood Collection Sets
K243806 · Promisemed Hangzhou Meditech Co., Ltd. · Jan 2025
ACE Cannula
K242741 · Ace Medical Industry Co., Ltd. · Jan 2025