# K981704: AUREX-3

- Pathway: 510(k) (Traditional)
- Applicant: Adm Tronics Unltd, Inc.
- Decided: Aug 5, 1998 after 83 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021202: Ultraquiet (2002), 1 descendant of its own
- K013253: Hisonic-TRD Tinnitus Relief Device (2002), 1 descendant of its own
- K070648: The Inhibitor, Model 001 (2007), 0 descendants of its own

## Indications for use
For use in treatment and control of tinnitus.

Source page: https://510kreport.com/device/K981704
Methodology: https://510kreport.com/methodology