# K942159: Novopen 1.5

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk Pharmaceuticals, Inc.
- Decided: Apr 26, 1995 after 358 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982966: Disetronic Pen (1998), 4 descendants of its own
- K070100: Haselmeier Pen (2007), 2 descendants of its own
- K083457: Tactipen (2009), 0 descendants of its own
- K082616: Haselmeier Pen 8 (2008), 0 descendants of its own
- K993666: Disetronic Pen P100 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K942159
Methodology: https://510kreport.com/methodology