Cleared Special

K140568 - CAREFINE PEN NEEDLE WITH QUINTAPOINT AN...

K140568 is an FDA 510(k) clearance for CAREFINE PEN NEEDLE WITH QUINTAPOINT AN..., manufactured by Facet Technologies, LLC. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 69-day FDA review.

K140568 · Facet Technologies, LLC · General Hospital
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May 2014
Decision
69d
Days
Class 2
Risk

K140568 is an FDA 510(k) clearance for the CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Facet Technologies, LLC (Kennesaw, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 69 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 Facet Technologies, LLC devices

FDA 510(k) Submission Details - K140568

510(k) Number K140568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date May 13, 2014
Days to Decision 69 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 272
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K140568.
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