# K221068: Sterile Hypodermic Syringes for Single Use with Needles

- Pathway: 510(k) (Traditional)
- Applicant: Sichuan Prius Biotechnology Co., Ltd.
- Decided: Oct 4, 2022 after 175 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 K771205 (1977). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211329: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Jiangsu Kangbao Medical Equipment Co., Ltd. (2021) Summary page 5.

## Indications for use
The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration and injection of fluids for medical purpose.

Source page: https://510kreport.com/device/K221068
Methodology: https://510kreport.com/methodology