# K151616: AT235

- Pathway: 510(k) (Special)
- Applicant: Interacoustics A/S
- Decided: Jul 15, 2015 after 30 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 K994254 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994254: Interacoustics AT235 Impedance Audiometer, International Distributors of Electronics For Medi (2000) Summary page 4.

## Indications for use
The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

Source page: https://510kreport.com/device/K151616
Methodology: https://510kreport.com/methodology