# K142518: HumaPen Luxura

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company
- Decided: Jun 5, 2015 after 270 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: 4 generations back to K895890 (1990). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100988: Humapen Luxura HD, Eli Lilly and Company (2010) Summary page 4.

## Most influential descendants
- K160668: HumaPen Savvio (2016), 1 descendant of its own
- K250262: GO-PEN® (2025), 0 descendants of its own
- K151686: HumanPen Ergo II (2015), 0 descendants of its own

## Indications for use
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).

Source page: https://510kreport.com/device/K142518
Methodology: https://510kreport.com/methodology