510(k) · Cleared
ClearedI-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurolign USA, LLC · GWN Nystagmograph
Cleared on Nov 29, 2019 as substantially equivalent to K083603 (Neuro Kinetics, 2009) and 2 other predicates after a 109-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Nov 29, 2019
- Review
- 109 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K083603 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK083603 I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal…Neuro Kinetics · 2009 · Recalled
- 2 generations backK143607 I-Portal NOTC, VNG and VOGNeuro Kinetics, Inc. · 2015 · Recalled
- 1 generation backK171884 I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017
- This deviceK192186 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography…Neurolign USA, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video… | Neuro Kinetics | 2009 | 4 |
| −2 | 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 | — |
| 0 (this device) | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System… | Neurolign USA, LLC | 2019 | — |
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? (3)
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 3…rm 100_18-45 is as following: I-Norm 100_18-45 is designed to be used with the family of I-Portal® devices: - I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607) - I-Portal® Video-Nystagmography System (VNG) – SVNG-2 (cleared by K143607) - I-Portal® Portable Assessment System™… | 2009 |
| * | K143607 | I-Portal NOTC, VNG and VOGSummary page 3…-45 is as following: I-Norm 100_18-45 is designed to be used with the family of I-Portal® devices: - I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607) - I-Portal® Video-Nystagmography System (VNG) – SVNG-2 (cleared by K143607) - I-Portal® Portable Assessment System™ Nystagmo… | 2015 |
| * | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS)Summary page 3…3603, K143607) - I-Portal® Video-Nystagmography System (VNG) – SVNG-2 (cleared by K143607) - I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884) The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnosti… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083603.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurologic, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range. The proposed intended use for I-Norm 100_18-45 is as following: I-Norm…
Read the full statement (150 words)
I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurologic, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range.
The proposed intended use for I-Norm 100_18-45 is as following:
I-Norm 100_18-45 is designed to be used with the family of I-Portal® devices:
- I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)
- I-Portal® Video-Nystagmography System (VNG) – SVNG-2 (cleared by K143607)
- I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884)
The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192186: I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192186
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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