# K053563: Humapen Memoir

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company
- Decided: Apr 7, 2006 after 107 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: 1 generation back to K010359 (2001). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010359: Innovo, Novo Nordisk A/S (2001) Summary page 1.

## Most influential descendants
- K093065: Finesse Personal Insulin Delivery Patch, Model FG-2000 (2010), 6 descendants of its own
- K100947: Finesse Personal Insulin Delivery Patch, Model FG 2000 (2010), 5 descendants of its own
- K111924: Finesse Personal Insulin Delivery Patch (2012), 4 descendants of its own
- K163357: OneTouch Via On-Demand Insulin Delivery System (2017), 3 descendants of its own
- K233447: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), 2 descendants of its own

## Indications for use
The HumaPen Memoir is 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® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.

Source page: https://510kreport.com/device/K053563
Methodology: https://510kreport.com/methodology