# K214080: Pentaflush

- Pathway: 510(k) (Traditional)
- Applicant: Pentaferte Italia S.R.L.
- Decided: Jul 20, 2022 after 205 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: 4 generations back to K053120 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192414: Praxiject 0.9% NaCl, Medxl, Inc. (2020) Summary page 4.

## Indications for use
Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices. May be placed on a sterile field. Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.

Source page: https://510kreport.com/device/K214080
Methodology: https://510kreport.com/methodology