# K192414: Praxiject 0.9% NaCl

- Pathway: 510(k) (Special)
- Applicant: Medxl, Inc.
- Decided: Feb 13, 2020 after 162 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: 3 generations back to K053120 (2005). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171109: Praxiject 0.9% NaCl, Medxl, Inc. (2017) Summary page 4.

## Most influential descendants
- K231754: Praxiject™ 0.9% NaCl (2023), 1 descendant of its own
- K233623: Praxiject™ SP 0.9% NaCl (2024), 0 descendants of its own
- K214080: Pentaflush (2022), 0 descendants of its own

## Indications for use
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

Source page: https://510kreport.com/device/K192414
Methodology: https://510kreport.com/methodology