# K013782: Disetronic Penfine Insulin Injection Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Nov 20, 2001 after 6 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: 3 generations back to K970737 (1997). 4 ancestors in all.
4 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)
- K982399: Disetronic Penfine Injection Pen Needle, Disetronic Medical Systems (1998) Summary page 1.
- K994197: Disentronic Penfine Injection Pen Needle, Disetronic Medical Systems (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K992399: Additional Ims Assays for the Bayer Advia Ims System, Bayer Corp. (1999). Our OCR of the scanned summary read K992399, FDA’s number for Additional Ims Assays for the Bayer Advia Ims System (Bayer Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Disetronic Penfine® Injection Pen Needles”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K100436: Clickfine Pen Needle (2010), 3 descendants of its own
- 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 Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.

Source page: https://510kreport.com/device/K013782
Methodology: https://510kreport.com/methodology