# K994197: Disentronic Penfine Injection Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems
- Decided: Dec 29, 1999 after 16 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: 2 generations back to K970737 (1997). 3 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982399: Disetronic Penfine Injection Pen Needle, Disetronic Medical Systems (1998) Summary page 1.

## Most influential descendants
- K102108: Clickfine Pen Needle (2010), 13 descendants of its own
- K110312: Clickfine Autoprotect Pen Needle (2012), 9 descendants of its own
- 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

## Indications for use
The Disetronic Penfine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.

Source page: https://510kreport.com/device/K994197
Methodology: https://510kreport.com/methodology