# K253747: Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Enjosim Medical Technology Co., Ltd.
- Decided: Aug 14, 2026 after 262 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: 6 generations back to K010359 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240961: Disposable Pen Injector Assembly, Wuxi Nest Biotechnology Co., Ltd. (2024) Summary page 5.

## Indications for use
The Disposable Pen Injector 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 uses 3mL cartridge of HUMALOG (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/K253747
Methodology: https://510kreport.com/methodology