Cleared Traditional

K131125 - CLICKFINE PEN NEEDLE

K131125 is an FDA 510(k) clearance for CLICKFINE PEN NEEDLE, manufactured by Ypsomed AG. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K131125 · Ypsomed AG · General Hospital
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Jul 2013
Decision
74d
Days
Class 2
Risk

K131125 is an FDA 510(k) clearance for the CLICKFINE PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on July 5, 2013 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ypsomed AG devices

FDA 510(k) Submission Details - K131125

510(k) Number K131125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date July 05, 2013
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 535
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K131125.
BD PEN NEEDLE
K131358 · Becton, Dickinson & CO · Jul 2013
EXTAVIPRO STERICAN 30G
K131040 · B.Braun Melsungen AG · Jul 2013
CLICKFINE AUTOPROTECT PEN NEEDLE
K131123 · Ypsomed AG · Jul 2013
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
K130487 · Pyng Medical Corp. · Jun 2013
SOL-CARE SAFETY NEEDLE
K123684 · Sol-Millennium Medical · May 2013
BD PEN NEEDLE
K123300 · Becton, Dickinson & CO · Jan 2013