# K100436: Clickfine Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Ypsomed AG
- Decided: Apr 30, 2010 after 73 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: 4 generations back to K970737 (1997). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013782: Disetronic Penfine Insulin Injection Pen Needle, Disetronic Medical Systems (2001) Summary page 1.

## Most influential descendants
- K122969: Clickfine Pen Needle (2012), 2 descendants of its own
- K131125: Clickfine Pen Needle (2013), 1 descendant of its own
- 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 the hypodermic injection of insulin into the body when attached to a pen-injector.

Source page: https://510kreport.com/device/K100436
Methodology: https://510kreport.com/methodology