# K231363: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

- Pathway: 510(k) (Traditional)
- Applicant: Hantech Medical Device Co., Ltd.
- Decided: Sep 27, 2023 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: 6 generations back to K984590 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213522: AMSafe Pre-Filled Normal Saline Flush Syringe, Amsino International, Inc. (2022) Summary page 5.

## Indications for use
The Hantech Pre-filled 0.9% Normal Saline 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/K231363
Methodology: https://510kreport.com/methodology