510(k) Report

FDA applicant

Ensodata, Inc.

Madison, WI3 decisions2017–20240 recalls

FDA records 3 decisions for Ensodata, Inc. (Madison, WI) from 2017 to 2024: 3 510(k) clearances. Most are in product codes OLZ (Automatic Event Detection Software For…) and MNR (Ventilatory Effort Recorder). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ensodata”.

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 Ensodata, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12021: 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 — Ensodata, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ensodata, 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?

  • OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2decisions
  • MNRVentilatory Effort Recorder1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K162627EnsoSleepEnsodata, Inc. · 20175cite it

What has FDA decided for it lately?

  • K231355AuroraEnsodata · 2024
  • K210034EnsoSleepEnsodata, Inc. · 2021
  • K162627EnsoSleepEnsodata, Inc. · 2017

All 2 as Ensodata, Inc. →The one decision as Ensodata →