Cleared Special

K152514 - Clickfine AutoProtect Pen Needle

K152514 is an FDA 510(k) clearance for Clickfine AutoProtect 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 77-day FDA review.

K152514 · Ypsomed AG · General Hospital
Download Printable Device Report (PDF)
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Nov 2015
Decision
77d
Days
Class 2
Risk

K152514 is an FDA 510(k) clearance for the Clickfine AutoProtect 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 18, 2015 after a review of 77 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 Ypsomed AG devices

FDA 510(k) Submission Details - K152514

510(k) Number K152514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date November 18, 2015
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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
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