# K222672: Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Hantech Medical Device Co., Ltd.
- Decided: Mar 6, 2023 after 181 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 K931367 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193273: Insulin Syringe, Promisemed Hangzhou Meditech Co., Ltd. (2021) Summary page 4.

## Indications for use
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K222672
Methodology: https://510kreport.com/methodology