510(k) Report

FDA applicant

Banyan Biomarkers, Inc.

San Diego, CA1 decision2018–20180 recalls

FDA records 1 decision for Banyan Biomarkers, Inc. (San Diego, CA) in 2018: 1 De Novo grant. All are in product code QAT (Brain Trauma Assessment Test). 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, immunology panel, where it files most

How often FDA has decided Banyan Biomarkers, 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

No recall linked to its devices since 2018.

FIG. 1 — Banyan Biomarkers, 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?

  • QATBrain Trauma Assessment Test1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • DEN170045Banyan BTIBanyan Biomarkers, Inc. · 20183cite it

What has FDA decided for it lately?

  • DEN170045Banyan BTIBanyan Biomarkers, Inc. · 2018

The one decision as Banyan Biomarkers, Inc. →

Other applicant names beginning “Banyan”

FDA records each applicant name separately; these may or may not be the same firm.

Banyan Medical, LLC 1Banyan USA, LLC 1