# K231792: VeriSafe Safety sterile syringes

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Sep 28, 2023 after 100 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: 9 generations back to K931367 (1993). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213560: Verifine Safety Syringe with Fixed Needle, Promisemed Hangzhou Meditech Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K250192: Verisafe Safety Retractable Insulin Syringes (2025), 0 descendants of its own

## Indications for use
It is intended to inject fluids into the body or withdraw blood for medical purposes. After injection, the needle tube will be retracted into the barrel when the safety features are manually activated to minimize the risk of accidental sharps injury.

Source page: https://510kreport.com/device/K231792
Methodology: https://510kreport.com/methodology