510(k) Report

FDA applicant

Medxl, Inc.

Pointe-Claire, CA4 decisions2017–20240 recalls

FDA records 4 decisions for Medxl, Inc. (Pointe-Claire, CA) from 2017 to 2024: 4 510(k) clearances. All are in product code NGT (Saline, Vascular Access Flush). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medxl, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12020: 12023: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Medxl, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medxl, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NGTSaline, Vascular Access Flush4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192414Praxiject 0.9% NaClMedxl, Inc. · 20202cite it
  • K171109Praxiject 0.9% NaClMedxl, Inc. · 20172cite it
  • K231754Praxiject™ 0.9% NaClMedxl, Inc. · 20231cites it

What has FDA decided for it lately?

  • K233623Praxiject™ SP 0.9% NaClMedxl, Inc. · 2024
  • K231754Praxiject™ 0.9% NaClMedxl, Inc. · 2023
  • K192414Praxiject 0.9% NaClMedxl, Inc. · 2020
  • K171109Praxiject 0.9% NaClMedxl, Inc. · 2017

All 4 as Medxl, Inc. →