# K160668: HumaPen Savvio

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company, Inc.
- Decided: Jun 3, 2016 after 86 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: 5 generations back to K895890 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142518: HumaPen Luxura, Eli Lilly and Company (2015) Summary page 4.

## Most influential descendants
- K250262: GO-PEN® (2025), 0 descendants of its own

## Indications for use
HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).

Source page: https://510kreport.com/device/K160668
Methodology: https://510kreport.com/methodology