# K151504: ICS Impulse

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics
- Decided: Nov 16, 2015 after 165 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 K991497 (1999). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061791: Focus VNG/Eng Type 1068, Gn Otometrics A/S (2006) Summary page 4.
- K122550: Ics Impulse, Gn Otometrics (2013) Summary page 4.

## Most influential descendants
- K242198: ICS Dizcovery (1091) (2025), 0 descendants of its own
- K242726: Synapsys VHIT (2025), 0 descendants of its own
- K163270: ISEN-Goggles with Data Viewer (2017), 0 descendants of its own

## Indications for use
The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

Source page: https://510kreport.com/device/K151504
Methodology: https://510kreport.com/methodology