Cleared Special

K243309 - 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

K243309 is an FDA 510(k) clearance for 27G x 1/2 TW K-Pack Surshield Needle (K..., manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 220-day FDA review.

K243309 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
220d
Days
Class 2
Risk

K243309 is an FDA 510(k) clearance for the 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT). 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 May 29, 2025 after a review of 220 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K243309

510(k) Number K243309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2024
Decision Date May 29, 2025
Days to Decision 220 days
Submission Type Special
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
91d slower than avg
Panel avg: 129d · This submission: 220d
Pathway characteristics
Modification to existing cleared device.

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 692
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K243309.
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K243581 · Terumo Europe N.V. · Apr 2025
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K250658 · Shina Med Corporation · Apr 2025
K243309 · 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
Download PDF FDA Summary Terumo Europe N.V.