# K982842: Humapen and Humapen Ergo

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Co.
- Decided: Sep 25, 1998 after 44 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) B-D Pen: named in the summary without a submission number

## Most influential descendants
- K070100: Haselmeier Pen (2007), 2 descendants of its own
- K083457: Tactipen (2009), 0 descendants of its own
- K082616: Haselmeier Pen 8 (2008), 0 descendants of its own
- K993666: Disetronic Pen P100 (1999), 0 descendants of its own

## Indications for use
The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen- injector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.

Source page: https://510kreport.com/device/K982842
Methodology: https://510kreport.com/methodology