Cleared Special

K150662 - Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

K150662 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 88-day FDA review.

K150662 · Ypsomed AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
88d
Days
Class 2
Risk

K150662 is an FDA 510(k) clearance for the Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated). 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 June 9, 2015 after a review of 88 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 - K150662

510(k) Number K150662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2015
Decision Date June 09, 2015
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K150662.
TM SAFETY NEEDLE
K142765 · Thinkmed Medical Technology Co., Ltd. · Aug 2015
Droplet Pen Needles
K143437 · Htl-Strefa S.A · Jun 2015
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · Terumo Europe N.V. · Jun 2015
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015
NIO -INTRAOSSEOUS DEVICE
K142086 · Waismed, Ltd. · Aug 2014
Terumo Pen Injector Needle 34
K140516 · Kofu Factory of Terumo Corp. · Aug 2014