Cleared Special

K171984 - Clickfine Pen Needle, Penfine Classic Pen Needle

K171984 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 103-day FDA review.

K171984 · Ypsomed AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
103d
Days
Class 2
Risk

K171984 is an FDA 510(k) clearance for the Clickfine Pen Needle, Penfine Classic 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 October 11, 2017 after a review of 103 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 - K171984

510(k) Number K171984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date October 11, 2017
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 Consultant

P/L Biomedical
Lee Leichter

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K171984.
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