Cleared Special

K132233 - K-PACK II NEEDLE - 27G X 3/4 THIN WALL

K132233 is an FDA 510(k) clearance for K-PACK II NEEDLE - 27G X 3/4 THIN WALL, 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 50-day FDA review.

K132233 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
50d
Days
Class 2
Risk

K132233 is an FDA 510(k) clearance for the K-PACK II NEEDLE - 27G X 3/4 THIN WALL. 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 September 6, 2013 after a review of 50 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.

View all Terumo Europe N.V. devices

FDA 510(k) Submission Details - K132233

510(k) Number K132233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2013
Decision Date September 06, 2013
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 454
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K132233.
CAREFINE PEN NEEDLE
K133100 · Facet Technologies · Jan 2014
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
K130212 · Wuxi Yushou Medical Applicances Co., Ltd. · Nov 2013
U&U STERILE HYPODERMIC NEEDLE
K132552 · U&U Medical Technology Co, Ltd. · Nov 2013
STERICAN CANNULA
K131842 · B.Braun Medical, Inc. · Aug 2013
BD PEN NEEDLE
K131358 · Becton, Dickinson & CO · Jul 2013
EXTAVIPRO STERICAN 30G
K131040 · B.Braun Melsungen AG · Jul 2013