# K130212: Safety Hypodermic Needles with/Without Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Yushou Medical Applicances Co., Ltd.
- Decided: Nov 20, 2013 after 295 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: 6 generations back to K904198 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 1.
- K110771: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2011) Summary page 2.

## Indications for use
The Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration and injection of fluids for medical purposes. The Safety Hypodermic Needle With/Without Syringe is compatible for use with standard luer slip and luer lock syringes. Additionally, 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 needle-stick.

Source page: https://510kreport.com/device/K130212
Methodology: https://510kreport.com/methodology