510(k) Report

FDA applicant

Neurovision Medical Products, Inc.

Ventura, CA9 decisions2010–201312 recalls

FDA records 9 decisions for Neurovision Medical Products, Inc. (Ventura, CA) from 2010 to 2013: 9 510(k) clearances. Most are in product codes ETN (Stimulator, Nerve) and BZQ (Monitor, Breathing Frequency). Its devices cite 14 predicates, 2 of them its own earlier devices. 12 recalls are linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Neurovision Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2010: 12011: 42012: 22013: 2
2010high 4 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2024

2020: 92021: 22024: 1
2010high 9 (2020) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Neurovision Medical Products, 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

Which product codes does it file in?

  • ETNStimulator, Nerve5decisions
  • BZQMonitor, Breathing Frequency1decision
  • PDQNeurosurgical Nerve Locator1decision
  • GWFStimulator, Electrical, Evoked Response1decision
  • FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device1decision

Whose devices does it build on?

Its devices cite 14 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 20113cite it
  • K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc. · 20112cite it
  • K110140Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc. · 20111cites it

What has FDA decided for it lately?

  • K130570Neurovision Medical Motion SensorNeurovision Medical Products, Inc. · 2013
  • K130806Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2013
  • K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 20122 recalls
  • K121931Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012
  • K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 201110 recalls
  • K110140Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc. · 2011
  • K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc. · 2011
  • K110138Paired Hydrogel ElectrodeNeurovision Medical Products, Inc. · 2011

All 9 as Neurovision Medical Products, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K110989Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex…Jul 1, 2024Class II
  • K113771SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact…Apr 8, 2021Class II
  • K113771SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact…Apr 8, 2021Class II
  • K110989Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx…Jul 21, 2020Class II
  • K110989Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI…Jul 21, 2020Class II
  • K110989Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI…Jul 21, 2020Class II

Other applicant names beginning “Neurovision”

FDA records each applicant name separately; these may or may not be the same firm.

Neurovision, Inc. 1Neurovision Imaging, LLC 1Neurovision Medical Product, Inc. 1