510(k) · Cleared
Recalled · Class II · 2015I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Kinetics · GWN Nystagmograph
Cleared on Aug 6, 2009 after a 244-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 6, 2009
- Review
- 244 days
- Class
- Class II
- Product code
- GWN
- Recalls
- 4
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK083603 I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal…Neuro Kinetics · 2009
- Descendant · cites it directly · 4 of its ownK143607 I-Portal NOTC, VNG and VOGNeuro Kinetics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK171884 I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK243709 NeuroEars-Anna™Neuroears, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK192186 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography…Neurolign USA, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK181025 I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography…Neuro Kinetics, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K143607I-Portal NOTC, VNG and VOGNeuro Kinetics, Inc. · 2015 · cites it directly4descendants
- K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017 · cites it directly1descendant
- K243709NeuroEars-Anna™Neuroears, Inc. · 2025 · 2 generations on0descendants
- K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…Neurolign USA, LLC · 2019 · cites it directly0descendants
- K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…Neuro Kinetics, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video… | Neuro Kinetics | 2009 | — |
| +1 | K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015 | 1 |
| +1 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017 | — |
| +2 | K243709 | NeuroEars-Anna™ | Neuroears, Inc. | 2025 | — |
| +1 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System… | Neurolign USA, LLC | 2019 | — |
| +2 | K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System… | Neuro Kinetics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWN device
- #1 K260566 SMARTVERTIGO™ Vestibular Assessment Systemscore 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2015 | Class II | Z-2730-2015 | No Marketing Application | The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. |
| Apr 30, 2015 | Class II | Z-1795-2015 | Software design | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. |
| Nov 21, 2013 | Class II | Z-0966-2014 | No Marketing Application | The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process. |
| Jul 24, 2009 | Not classified | Z-2253-2009 | PMA | Marketed without a 510k or PMA submission to include the normative data display. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143607 (Neuro Kinetics, Inc., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWN
203in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWN
1in 2025
MAUDE reports naming product code GWN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 3 | 88 | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 165 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 4 | 160 | 0 | 0 |
| 2018 | 3 | 87 | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 3 | 203 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. I-Portal® 4D Video…
Read the full statement (203 words)
I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083603: I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026