FDA applicant

Advanced Brain Monitoring, Inc.

Dousman, WI15 decisions2004–20180 recalls

FDA records 15 decisions for Advanced Brain Monitoring, Inc. (Dousman, WI) from 2004 to 2018: 15 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and OLZ (Automatic Event Detection Software For…). Its devices cite 22 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Advanced Brain Monitoring”.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2018

2007high 3 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Brain Monitoring, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Advanced Brain Monitoring, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?