# K111034: AM Usa 0.9% Sodium Chloride Flush Syringe

- Pathway: 510(k) (Special)
- Applicant: Am USA
- Decided: Jul 14, 2011 after 92 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984590 (1999). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984590: 0.9% Sodium Chloride Flush Syringe, Baxter Healthcare Corp (1999) Summary page 2.

## Most influential descendants
- K120836: 0.9% Sodium Chloride Flish Syringe (2012), 6 descendants of its own
- K133685: 0.9% Sodium Chloride Flush Syringe (2014), 5 descendants of its own
- K183473: AMSafe (R) Pre-Filled Normal Saline Flush Syringe (2019), 4 descendants of its own
- K213522: AMSafe Pre-Filled Normal Saline Flush Syringe (2022), 2 descendants of its own
- K231724: Flush Syringe (Prefilled 0.9% normal saline solution) (2023), 0 descendants of its own

## Recalls of this device
- Aug 15, 2012 · Class III · Z-2394-2012: One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
- Aug 15, 2012 · Class III · Z-2393-2012: One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.

## 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/K111034
Methodology: https://510kreport.com/methodology