# K254273: Verisafe Safety Sterile Needles (SSN)

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Apr 16, 2026 after 107 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
It is intended for use with syringes for general purpose fluid injections and withdrawal. When the safety shield is activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.

Source page: https://510kreport.com/device/K254273
Methodology: https://510kreport.com/methodology