510(k) · Cleared
Recalled · Class II · 2015I-Portal NOTC, VNG and VOG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Kinetics, Inc. · GWN Nystagmograph
Cleared on Jul 8, 2015 as substantially equivalent to K083603 (Neuro Kinetics, 2009) after a 201-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2015
- Review
- 201 days
- Class
- Class II
- Product code
- GWN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083603 (2009). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK083603 I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal…Neuro Kinetics · 2009 · Recalled
- This deviceK143607 I-Portal NOTC, VNG and VOGNeuro Kinetics, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK171884 I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK181025 I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography…Neuro Kinetics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017 · cites it directly1descendant
- K243709NeuroEars-Anna™Neuroears, Inc. · 2025 · cites it directly0descendants
- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video… | Neuro Kinetics | 2009 | 4 |
| 0 (this device) | K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015 | — |
| +1 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017 | — |
| +1 | K243709 | NeuroEars-Anna™ | Neuroears, Inc. | 2025 | — |
| +1 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System… | Neurolign USA, LLC | 2019 | — |
| +1 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography…Summary page 4…stagmograph Classification Name: Nystagmograph (21 CFR 882.1460, Product Code GWN) Predicate Device I-Portal® NOTC, I-Portal® VNG, I-Portal® 4D VOG System (K083603) Device Description The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as “a device used to measure,… | 2009 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | 2017 | 1 |
| K243709 | NeuroEars-Anna™ | 2025 | 0 |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal… | 2019 | 0 |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal… | 2018 | 0 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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) 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…
Read the full statement (216 words)
I-Portal® Neuro Otologic Test Center (NOTC)
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® Video-Nystagmography System (VNG)
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.
I-Portal® Video Oculography (VOG) System
I-Portal® 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143607 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143607: I-Portal NOTC, VNG and VOG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143607
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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