# K110312: Clickfine Autoprotect Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ypsomed AG
- Decided: Jan 26, 2012 after 358 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.
9 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102108: Clickfine Pen Needle, Ypsomed AG (2010) Summary page 1.

## Most influential descendants
- K131123: Clickfine Autoprotect Pen Needle (2013), 8 descendants of its own
- K152514: Clickfine AutoProtect Pen Needle (2015), 7 descendants of its own
- K181447: Safety insulin needle for single use (2019), 4 descendants of its own
- K210864: Safety Pen Needle (2022), 1 descendant of its own
- K192677: Safety Insulin Pen Needle (2020), 1 descendant of its own

## Indications for use
The Clickfine AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

Source page: https://510kreport.com/device/K110312
Methodology: https://510kreport.com/methodology