# K223453: Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Mar 2, 2023 after 106 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 K931367 (1993). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110421: Disposable Insulin Syringe, Wenzhou Wuzhou Import & Export Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K253068: Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (2026), 0 descendants of its own
- K233794: Insulin Syringe (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K223453
Methodology: https://510kreport.com/methodology