# K171884: I-Portal Portable Assessment System - Nystagmograph (I-PAS)

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Kinetics, Inc.
- Decided: Nov 22, 2017 after 152 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083603 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083603: I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol, Neuro Kinetics (2009) Summary page 4.
- K143607: I-Portal NOTC, VNG and VOG, Neuro Kinetics, Inc. (2015) Summary page 4.

## Most influential descendants
- K192186: I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K171884
Methodology: https://510kreport.com/methodology