# K242434: Insulin Syringes

- Pathway: 510(k) (Special)
- Applicant: Chirana T. Injecta
- Decided: Dec 24, 2024 after 130 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: 8 generations back to K931367 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201044: CHIRANA Insulin Syringes, Chirana T. Injecta (2022) Summary page 5.

## Indications for use
The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

Source page: https://510kreport.com/device/K242434
Methodology: https://510kreport.com/methodology