510(k) · Cleared
ClearedI-Portal Portable Assessment System - Nystagmograph (I-PAS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Kinetics, Inc. · GWN Nystagmograph
Cleared on Nov 22, 2017 as substantially equivalent to K083603 (Neuro Kinetics, 2009) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Nov 22, 2017
- Review
- 152 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K083603 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK083603 I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal…Neuro Kinetics · 2009 · Recalled
- 1 generation backK143607 I-Portal NOTC, VNG and VOGNeuro Kinetics, Inc. · 2015 · Recalled
- This deviceK171884 I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK192186 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography…Neurolign USA, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…Neurolign USA, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video… | Neuro Kinetics | 2009 | 4 |
| −1 | K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015 | 1 |
| 0 (this device) | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017 | — |
| +1 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System… | Neurolign USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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…mon Name: Nystagmograph Classification Name: Nystagmograph (21 CFR 882.1460, Product Code GWN) Predicate Device I-Portal® VNG (K083603 & K143607) Device Description All I-Portal® devices, including the proposed I-PAS, function as nystagmographs, defined by 21 CF… | 2009 |
| * | K143607 | I-Portal NOTC, VNG and VOGSummary page 4…Nystagmograph Classification Name: Nystagmograph (21 CFR 882.1460, Product Code GWN) Predicate Device I-Portal® VNG (K083603 & K143607) Device Description All I-Portal® devices, including the proposed I-PAS, function as nystagmographs, defined by 21 CFR 882.1460… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal… | 2019 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K192186 (Neurolign USA, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS 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 does not provide diagnoses nor does it provide diagnostic recommendations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171884: I-Portal Portable Assessment System - Nystagmograph (I-PAS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171884
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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