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

- Pathway: 510(k) (Special)
- Applicant: Ypsomed AG
- Decided: Jun 9, 2015 after 88 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: 7 generations back to K970737 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131125: Clickfine Pen Needle, Ypsomed AG (2013) Summary page 4.

## Indications for use
The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Source page: https://510kreport.com/device/K150662
Methodology: https://510kreport.com/methodology