# K180259: Sterile Hypodermic Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Shenli Medical Production Co., Ltd.
- Decided: May 18, 2018 after 108 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: 3 generations back to K944355 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102584: Imc Hypodermic Needle, International Medsurg Connection (2011) Summary page 4.

## Indications for use
This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K180259
Methodology: https://510kreport.com/methodology