# K103740: Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Jul 29, 2011 after 219 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023740 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule, Spectra Medical Devices, Inc. (2009) Summary page 2.
- K023740: Syrex Pre-Filled Syringe, Excelsior Medical Corp. (2003) Summary page 2.

## Recalls of this device
- Jul 6, 2026 · Class I · Z-2873-2026: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or fo

## Indications for use
The device is indicated only for use in flushing compatible intravenous tubing systems and in dwelling intravascular access devices. Not to be used for any other purposes.

Source page: https://510kreport.com/device/K103740
Methodology: https://510kreport.com/methodology