Cleared Traditional

K140516 - Terumo Pen Injector Needle 34

K140516 is an FDA 510(k) clearance for Terumo Pen Injector Needle 34, manufactured by Kofu Factory of Terumo Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K140516 · Kofu Factory of Terumo Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
158d
Days
Class 2
Risk

K140516 is an FDA 510(k) clearance for the Terumo Pen Injector Needle 34. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Kofu Factory of Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on August 5, 2014 after a review of 158 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. 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.

FDA 510(k) Submission Details - K140516

510(k) Number K140516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date August 05, 2014
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 597
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K140516.
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
K150662 · Ypsomed AG · Jun 2015
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015
NIO -INTRAOSSEOUS DEVICE
K142086 · Waismed, Ltd. · Aug 2014
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
K141749 · Facet Technologies, LLC · Jul 2014
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
K130097 · American Medical Manufacturing, Inc./ Advanced Med · Jul 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K141117 · Vidacare, LLC · Jul 2014