510(k) Report

FDA applicant

Cerebrotech Medical Systems, Inc.

Pleasanton, CA2 decisions2017–20180 recalls

FDA records 2 decisions for Cerebrotech Medical Systems, Inc. (Pleasanton, CA) from 2017 to 2018: 2 510(k) clearances. All are in product code QAF (Impedance Plethysmograph, Cranial). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cerebrotech Medical Systems”.

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 Cerebrotech Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

Planning a device like Cerebrotech Medical Systems, 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?

  • QAFImpedance Plethysmograph, Cranial2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K182967Visor SystemCerebrotech Medical Systems, Inc. · 20181cites it
  • K171186Cerebrotech CMS-5000Cerebrotech Medical Systems · 20171cites it

What has FDA decided for it lately?

  • K182967Visor SystemCerebrotech Medical Systems, Inc. · 2018
  • K171186Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017

The one decision as Cerebrotech Medical Systems, Inc. →The one decision as Cerebrotech Medical Systems →