# K131125: Clickfine Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ypsomed AG
- Decided: Jul 5, 2013 after 74 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970737 (1997). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122969: Clickfine Pen Needle, P/L Biomedical (2012) Summary page 1.
- K122971: Clickfine Pen Needle, P/L Biomedical (2012) Summary page 1.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K101105: Powder-Free, Natural Color, Latex Examination Glove Model: MEPF1, Best Putra Gloves Sdn Bhd (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150662: Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (2015), 0 descendants of its own

## Indications for use
The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Source page: https://510kreport.com/device/K131125
Methodology: https://510kreport.com/methodology