# K240774: Pen Injector

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Nest Biotechnology Co., Ltd.
- Decided: Jun 18, 2024 after 89 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 K010359 (2001). 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)
- K182387: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector), Novo Nordisk, Inc. (2018) Summary page 4.

## Indications for use
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G*4mm, 31G*4mm, 31G*5mm, and 31G*6mm).

Source page: https://510kreport.com/device/K240774
Methodology: https://510kreport.com/methodology