# K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Mar 20, 2009 after 186 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: 1 generation back to K023740 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023740: Syrex Pre-Filled Syringe, Excelsior Medical Corp. (2003) Summary page 2.

## Most influential descendants
- K103740: Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule (2011), 0 descendants of its own

## 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/K082689
Methodology: https://510kreport.com/methodology