# K222271: Verisafe Safety sterile needles

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Feb 15, 2023 after 201 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
Longest line of descent: 2 generations back to K010188 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123684: Sol-Care Safety Needle, Sol-Millennium Medical (2013) Summary page 5.

## Indications for use
It is intended for use in the aspiration and injection of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.

Source page: https://510kreport.com/device/K222271
Methodology: https://510kreport.com/methodology