# K100988: Humapen Luxura HD

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company
- Decided: Aug 17, 2010 after 130 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: 3 generations back to K895890 (1990). 3 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K063151: Humapen Luxura HD, Eli Lilly and Co. (2007) Summary page 1.

## Most influential descendants
- K142518: HumaPen Luxura (2015), 3 descendants of its own
- 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
The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

Source page: https://510kreport.com/device/K100988
Methodology: https://510kreport.com/methodology