# K131123: Clickfine Autoprotect 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: 5 generations back to K970737 (1997). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110312: Clickfine Autoprotect Pen Needle, Ypsomed AG (2012) Summary page 2.
- K060007: BD Autoshield Pen Needle, Becton, Dickinson & CO (2006) Summary page 1.

## Most influential descendants
- 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
- K253622: Safety Pen Needle (2026), 0 descendants of its own

## Indications for use
The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Source page: https://510kreport.com/device/K131123
Methodology: https://510kreport.com/methodology