# K221080: Sterile Safety Hypodermic Needles for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Sichuan Prius Biotechnology Co., Ltd.
- Decided: Oct 4, 2022 after 175 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: 7 generations back to K904198 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use, Berpu Medical Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K221080
Methodology: https://510kreport.com/methodology