# K222417: Shina Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shina Corporation
- Decided: Mar 20, 2023 after 222 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
Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes. Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

Source page: https://510kreport.com/device/K222417
Methodology: https://510kreport.com/methodology