Cleared Special

K150263 - K-Pack II Needle-21G x 2

K150263 is an FDA 510(k) clearance for K-Pack II Needle-21G x 2, 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 56-day FDA review.

K150263 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
56d
Days
Class 2
Risk

K150263 is an FDA 510(k) clearance for the K-Pack II Needle-21G x 2. 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 1, 2015 after a review of 56 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K150263

510(k) Number K150263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2015
Decision Date April 01, 2015
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 694
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K150263.
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NIO -INTRAOSSEOUS DEVICE
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K150263 · K-Pack II Needle-21G x 2
Download PDF FDA Summary Terumo Europe N.V.