510(k) Report

FDA applicant

Avertix Medical, Inc.

Eatontown1 decision2018–20181 recall

FDA records 1 decision for Avertix Medical, Inc. (Eatontown) in 2018: 1 original PMA approval. All are in product code QBI (Acute Coronary Syndrome Event Detector). 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2018high 1 (2023) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Avertix Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QBIAcute Coronary Syndrome Event Detector1decision

What has FDA decided for it lately?

  • P150009Guardian SystemAvertix Medical, Inc. · 20181 recall

The one decision as Avertix Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P150009Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model…Sep 1, 2023Class II