# K230756: TK Pre-Filled Normal Saline Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Aug 12, 2023 after 145 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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
The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing of indwelling vascular access devices.

Source page: https://510kreport.com/device/K230756
Methodology: https://510kreport.com/methodology