# K201044: CHIRANA Insulin Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Chirana T. Injecta
- Decided: Jan 18, 2022 after 637 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: 7 generations back to K931367 (1993). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use, Shanghai Kohope Medical Devices Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K242434: Insulin Syringes (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K201044
Methodology: https://510kreport.com/methodology