# K022057: KG Medix Disposable Syring, 1,3,5,10, 20, 30, 50 ML'S,KG Medix

- Pathway: 510(k) (Traditional)
- Applicant: Kyung GI Medical Ind. Co., Ltd.
- Decided: Nov 22, 2002 after 151 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Hypodermic single lumen needle: To inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin Piston Syringe: To inject fluids into, or withdraw fluids from the body

Source page: https://510kreport.com/device/K022057
Methodology: https://510kreport.com/methodology