# K213560: Verifine Safety Syringe with Fixed Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Apr 5, 2022 after 147 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: 8 generations back to K931367 (1993). 24 ancestors in all.
2 later devices descend 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)
- K211242: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes, Promisemed Hangzhou Meditech Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K231792: VeriSafe Safety sterile syringes (2023), 1 descendant of its own
- K250192: Verisafe Safety Retractable Insulin Syringes (2025), 0 descendants of its own

## Indications for use
It is intended to inject fluids into or withdraw fluids from the body for medical purposes.

Source page: https://510kreport.com/device/K213560
Methodology: https://510kreport.com/methodology