# K970685: Earcheck Pro

- Pathway: 510(k) (Traditional)
- Applicant: Mdi Instruments, Inc.
- Decided: May 28, 1997 after 93 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acoustic Reflectometer: named in the summary without a submission number
- (no number) Tympanometer: named in the summary without a submission number

## Most influential descendants
- K971859: Earcheck (1997), 0 descendants of its own

## Indications for use
EarCheck Pro is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The instrument is designed for use by doctors and other medical professionals on children from 6 months to young adult.

Source page: https://510kreport.com/device/K970685
Methodology: https://510kreport.com/methodology