Cleared Special

K102108 - CLICKFINE PEN NEEDLE

K102108 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 Special 510(k) pathway after a 119-day FDA review.

K102108 · Ypsomed AG · General Hospital
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Nov 2010
Decision
119d
Days
Class 2
Risk

K102108 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 November 23, 2010 after a review of 119 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ypsomed AG devices

FDA 510(k) Submission Details - K102108

510(k) Number K102108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date November 23, 2010
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 535
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K102108.
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