# K250262: GO-PEN®

- Pathway: 510(k) (Traditional)
- Applicant: Go-Pen Aps
- Decided: Apr 24, 2025 after 85 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
Longest line of descent: 6 generations back to K895890 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160668: HumaPen Savvio, Eli Lilly and Company, Inc. (2016) Summary page 5.

## Indications for use
GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.

Source page: https://510kreport.com/device/K250262
Methodology: https://510kreport.com/methodology