# K130230: Sterile Piston Hypodermic Syringes (with/Without Needle), Hypodermic Needles

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Yushou Medical Applicances Co., Ltd.
- Decided: Nov 20, 2013 after 295 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: 3 generations back to K931367 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110771: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2011) Summary page 2.
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 4.

## Indications for use
Sterile Piston Hypodermic Syringes (With/Without Needle) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.

Source page: https://510kreport.com/device/K130230
Methodology: https://510kreport.com/methodology