# K002403: Novofine 31 Disposable Needle

- Pathway: 510(k) (Traditional)
- Applicant: Novo Norodisk Pharmaceuticals, Inc.
- Decided: Dec 8, 2000 after 123 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.
37 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050106: Novofine Autocover 30G X 8MM (2005), 34 descendants of its own
- K053470: Novofine 32G Tip (2005), 18 descendants of its own
- K062500: Flexpen Needle (2006), 17 descendants of its own
- K090111: Flexpen Needle (2010), 16 descendants of its own
- K151311: Safe Block Pen Needle (2016), 11 descendants of its own

Source page: https://510kreport.com/device/K002403
Methodology: https://510kreport.com/methodology