# K240961: Disposable Pen Injector Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Nest Biotechnology Co., Ltd.
- Decided: Aug 15, 2024 after 129 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K253747: Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (2026), 0 descendants of its own

## Indications for use
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.

Source page: https://510kreport.com/device/K240961
Methodology: https://510kreport.com/methodology