Cleared Special

K122969 - CLICKFINE PEN NEEDLE

K122969 is an FDA 510(k) clearance for CLICKFINE PEN NEEDLE, manufactured by P/L Biomedical. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 29-day FDA review.

K122969 · P/L Biomedical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
29d
Days
Class 2
Risk

K122969 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 P/L Biomedical (Fort Myers, US). The FDA issued a Cleared decision on October 25, 2012 after a review of 29 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.

FDA 510(k) Submission Details - K122969

510(k) Number K122969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date October 25, 2012
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 608
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K122969.
SOL-CARE SAFETY NEEDLE
K123684 · Sol-Millennium Medical · May 2013
BD PEN NEEDLE
K123300 · Becton, Dickinson & CO · Jan 2013
TERUMO(R) NEEDLE
K121607 · Terumo (Philippines) Corporation · Nov 2012
CLICKFINE PEN NEEDLE
K122971 · P/L Biomedical · Oct 2012
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · Nipro Medical Corporation · Oct 2012
STERILE BLUNT FOR SINGLE USE
K120420 · Shanghai Double Dove Industrial Co., Ltd. · Oct 2012
K122969 · CLICKFINE PEN NEEDLE
Download PDF FDA Summary P/L Biomedical