# K142620: 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corporation
- Decided: Dec 12, 2014 after 87 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K053120 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962938: Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride), Excelsior Medical Corp. (1996) Summary page 4.
- K082837: Sterile Field Saline Pre-Filled Syringe (S), Excelsior Medical Corp. (2008) Summary page 4.

## Recalls of this device
- Feb 1, 2018 · Class II · Z-2948-2018: Packaged with an incorrect overwrap.

## Indications for use
0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Source page: https://510kreport.com/device/K142620
Methodology: https://510kreport.com/methodology