# K973339: Disetronic Penfine Injection Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Sep 24, 1997 after 19 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
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Novo Nordisk NovoFine 30 Injection Pen Needles: named in the summary without a submission number
- (no number) Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Injection Pen Needles: named in the summary without a submission number

## Most influential descendants
- K982399: Disetronic Penfine Injection Pen Needle (1998), 18 descendants of its own
- K994197: Disentronic Penfine Injection Pen Needle (1999), 17 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K973339
Methodology: https://510kreport.com/methodology