510(k) Report

FDA applicant

Neurovirtual USA, Inc.

Doral, FL8 decisions2006–20200 recalls

FDA records 8 decisions for Neurovirtual USA, Inc. (Doral, FL) from 2006 to 2020: 8 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and GWQ (Full-Montage Standard Electroencephalograph). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 2 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 Neurovirtual USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2011: 12015: 12017: 12019: 12020: 3
2007high 3 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Neurovirtual USA, 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?

  • MNRVentilatory Effort Recorder3decisions
  • GWQFull-Montage Standard Electroencephalograph3decisions
  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision
  • GXYElectrode, Cutaneous1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 266 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 192 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 20061cites it
  • K131335Bwmini Eeg, Bwminihst, Bwmini PSGNeurovirtual USA, Inc. · 20151cites it

What has FDA decided for it lately?

  • K201495Maxxi Flow SensorNeurovirtual USA, Inc. · 2020
  • K191492Maxxi Position SensorNeurovirtual USA, Inc. · 2020
  • K191095Maxxi Snore SensorNeurovirtual USA, Inc. · 2020
  • K171304Maxxi Rip SensorNeurovirtual USA, Inc. · 2019
  • K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. · 2017
  • K131335Bwmini Eeg, Bwminihst, Bwmini PSGNeurovirtual USA, Inc. · 2015
  • K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011
  • K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006

All 8 as Neurovirtual USA, Inc. →