# K971859: Earcheck

- Pathway: 510(k) (Traditional)
- Applicant: Mdi Instruments, Inc.
- Decided: Aug 18, 1997 after 90 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 K970685 (1997). 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)
- K970685: Earcheck Pro, Mdi Instruments, Inc. (1997). Cleared while this submission was under review Summary page 1.

## Indications for use
EarCheck 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 device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.

Source page: https://510kreport.com/device/K971859
Methodology: https://510kreport.com/methodology