# K231165: Shina Syringe; Shina Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Shina Med Corporation
- Decided: Oct 27, 2023 after 185 days
- Product code: MEG (Syringe, Antistick)
- 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe, Poonglim Pharmatech, Inc. (2021) Summary page 5.
- K210444: EZ-Injec LDV Sterile Safety Needle, Poonglim Pharmatech, Inc. (2021) Summary page 5.

## Indications for use
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

Source page: https://510kreport.com/device/K231165
Methodology: https://510kreport.com/methodology