# K213522: AMSafe Pre-Filled Normal Saline Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Mar 22, 2022 after 139 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.
2 later devices descend from it; 2 cite it directly.
0 of 8 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 4.

## Most influential descendants
- K231363: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) (2023), 0 descendants of its own
- K223584: Pre-Filled Normal Saline Flush Syringe (2023), 0 descendants of its own

## Indications for use
The AMSafe@ Pre-Filled Normal Saline Flush Syringe, is 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/K213522
Methodology: https://510kreport.com/methodology