510(k) Report

FDA applicant

Neurowave Systems, Inc.

Cleveland Heights, OH3 decisions2010–20210 recalls

FDA records 3 decisions for Neurowave Systems, Inc. (Cleveland Heights, OH) from 2010 to 2021: 3 510(k) clearances. Most are in product codes OLT (Non-Normalizing Quantitative…) and OLW (Index-Generating Electroencephalograph Software). Its devices cite 5 predicates, 1 of them its own earlier devices. 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, neurology panel, where it files most

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

FDA decisions per year

1in 2021

2010: 12015: 12021: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Neurowave Systems, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision
  • OLWIndex-Generating Electroencephalograph Software1decision
  • OMCReduced- Montage Standard Electroencephalograph1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 20152cite it
  • K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 20101cites it

What has FDA decided for it lately?

  • K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc. · 2021
  • K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
  • K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc. · 2010

All 3 as Neurowave Systems, Inc. →