# K231724: Flush Syringe (Prefilled 0.9% normal saline solution)

- Pathway: 510(k) (Traditional)
- Applicant: Spm Medicare Pvt., Ltd.
- Decided: Nov 9, 2023 after 149 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K984590 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183473: AMSafe (R) Pre-Filled Normal Saline Flush Syringe, Amsino International, Inc. (2019) Summary page 6.

## Indications for use
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Source page: https://510kreport.com/device/K231724
Methodology: https://510kreport.com/methodology