# K150163: Otowave 202 Portable Tympanometer

- Pathway: 510(k) (Traditional)
- Applicant: Amplivox, Ltd.
- Decided: Apr 23, 2015 after 87 days
- Product code: NAS (Tympanometer)
- 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: 2 generations back to K925585 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081841: Amplivox Otowave 102 Hand Held Portable Tympanometer, Amplivox, Ltd. (2008) Summary page 4.

## Indications for use
The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population 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/K150163
Methodology: https://510kreport.com/methodology