Cleared Special

K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (K192057) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192057 · Terumo Europe N.V. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
71d
Days
Class 2
Risk

K192057 is an FDA 510(k) clearance for the K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” .... 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 October 11, 2019 after a review of 71 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

Submission Details

510(k) Number K192057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2019
Decision Date October 11, 2019
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K192057.
SAM IO Intraosseous Access System
K191488 · Sam? Medical Products, Inc. · Nov 2019
Piper GO-IO Intraosseous Infusion System
K191976 · Piper Access, LLC · Nov 2019
Intraosseous infusion device
K191258 · Einstein Works, LLC · Oct 2019
NIO-I
K190538 · Waismed, Ltd. · Oct 2019
Dual-Safety Pen Needle
K191853 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2019
SteriCap Mini Needle
K183016 · Ocujet, LLC · May 2019