# K041853: Otogram

- Pathway: 510(k) (Traditional)
- Applicant: Tympany, Inc.
- Decided: Sep 3, 2004 after 57 days
- Product code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)
- Device class: 2
- Regulation: 21 CFR 874.3310
- 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 K910247 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910247: Zodiac 901 Middle-Ear Analyzer, Madsen Electronics (Canada), Ltd. (1991) Summary page 1.
- K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe, Bio-Logic Systems Corp. (1998) Summary page 1.

## Indications for use
"Otogram" can perform the functions of: 1. Pure tone and speech audiometer, 2. Impedance audiometer (tympanometry, acoustic reflex), and 3. Distortion product otoacoustic emissions analyzer. The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

Source page: https://510kreport.com/device/K041853
Methodology: https://510kreport.com/methodology