# K010359: Innovo

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk A/S
- Decided: Mar 14, 2001 after 36 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.
37 later devices descend from it; 2 cite it directly.
1 of 38 devices in its family (counting itself) has 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
- K123766: Novopen Echo, a Dial a Dose Insulin Delivery Pen (2013), 28 descendants of its own
- K160629: InPen (2016), 21 descendants of its own
- K190487: InPen Dose Calculator (2020), 10 descendants of its own
- K201337: InPen System (2020), 7 descendants of its own
- K053563: Humapen Memoir (2006), 7 descendants of its own

Source page: https://510kreport.com/device/K010359
Methodology: https://510kreport.com/methodology