# K171109: Praxiject 0.9% NaCl

- Pathway: 510(k) (Traditional)
- Applicant: Medxl, Inc.
- Decided: Dec 21, 2017 after 251 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: 2 generations back to K053120 (2005). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082837: Sterile Field Saline Pre-Filled Syringe (S), Excelsior Medical Corp. (2008) Summary page 4.

## Most influential descendants
- K192414: Praxiject 0.9% NaCl (2020), 3 descendants of its own
- K231754: Praxiject™ 0.9% NaCl (2023), 1 descendant of its own
- K201286: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (2020), 1 descendant of its own
- K243484: PM2+ System and SmartPICC Stylet (2025), 0 descendants of its own
- K233623: Praxiject™ SP 0.9% NaCl (2024), 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/K171109
Methodology: https://510kreport.com/methodology