# K113555: AM Usa 0.9% Sodium Chloride Flush Syringe

- Pathway: 510(k) (Special)
- Applicant: Am USA
- Decided: Jan 30, 2012 after 60 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 K984590 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111034: AM Usa 0.9% Sodium Chloride Flush Syringe, Am USA (2011)

## Recalls of this device
- Dec 28, 2023 · Class II · Z-1174-2024: The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.

## Indications for use
0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.

Source page: https://510kreport.com/device/K113555
Methodology: https://510kreport.com/methodology