# K242954: Integrity V500 (Integrity, Integrity with VEMP)

- Pathway: 510(k) (Traditional)
- Applicant: Vivosonic, Inc.
- Decided: Dec 19, 2024 after 85 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002985 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162037: Eclipse with VEMP, Interacoustics A/S (2017) Summary page 5.

## Indications for use
The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.

Source page: https://510kreport.com/device/K242954
Methodology: https://510kreport.com/methodology