# K210712: Verifine Mechanical Safety Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Sep 8, 2021 after 182 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
It is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. The safety shield is intended to reduce the risk of sharp injuries.

Source page: https://510kreport.com/device/K210712
Methodology: https://510kreport.com/methodology