# K191378: 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 15, 2019 after 115 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 0.9% Sodium Chloride Injection, USP, Pre-filled Syringe is intended for flushing of IV catheters and IV tubing only. The syringe is provided to convenience kit packers/OEMs to be placed in surgical procedure kits that may undergo ethylene oxide (EO) sterilization according to their validated processes per ANSI/AAMI/ISO 11135:2014.

Source page: https://510kreport.com/device/K191378
Methodology: https://510kreport.com/methodology