# K151686: HumanPen Ergo II

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company, Inc.
- Decided: Dec 30, 2015 after 190 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.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
HumaPen Ergo II 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/K151686
Methodology: https://510kreport.com/methodology