# K984590: 0.9% Sodium Chloride Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 7, 1999 after 283 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- 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
No predicates in its family tree.
10 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott prefilled syringe with 0.9% sodium chloride solution: named in the summary without a submission number

## Most influential descendants
- K111034: AM Usa 0.9% Sodium Chloride Flush Syringe (2011), 9 descendants of its own
- 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

## Recalls of this device
- Dec 12, 2002 · Not classified · Z-0456-03: Sterility questioned

## Indications for use
The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Source page: https://510kreport.com/device/K984590
Methodology: https://510kreport.com/methodology