# K081841: Amplivox Otowave 102 Hand Held Portable Tympanometer

- Pathway: 510(k) (Traditional)
- Applicant: Amplivox, Ltd.
- Decided: Jul 16, 2008 after 16 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925585 (1993). 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)
- K925585: Gsi 38 Auto Tymp, Lucas Grason-Stadler, Inc. (1993) Summary page 1.
- K060885: Model MI 44 Tympanometer, Maico-Diagnostics (2006) Summary page 1.

## Most influential descendants
- K150163: Otowave 202 Portable Tympanometer (2015), 0 descendants of its own

## Indications for use
The Amplivox Otowave is designed for use by trained operators in hospitals. ENT clinics, and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the compliance of the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected. reflex measurement is automatically carried out after a tympanogram is taken.

Source page: https://510kreport.com/device/K081841
Methodology: https://510kreport.com/methodology