# K120836: 0.9% Sodium Chloride Flish Syringe

- Pathway: 510(k) (Special)
- Applicant: Am USA
- Decided: Jul 12, 2012 after 114 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: 2 generations back to K984590 (1999). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 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)

## Most influential descendants
- 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
- K231363: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (2023), 0 descendants of its own

## Recalls of this device
- Jul 2, 2015 · Class II · Z-2476-2015: Procedures for the acceptance and control of in-process product have not been adequately established.
- Feb 9, 2015 · Class II · Z-1808-2015: Incorrect labeling of the expiration date

## 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 manufacturer for the appropriate device.

Source page: https://510kreport.com/device/K120836
Methodology: https://510kreport.com/methodology