# K974235: Amplaid AM50

- Pathway: 510(k) (Traditional)
- Applicant: Amplifon S.P.A.
- Decided: Feb 10, 1998 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 K802097 (1980). 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)
- K802097: Self-Recording Admittance Meter 709, Amplaid USA, Inc. (1980) Summary page 1.
- K903066: Amplaid 770 Admittance Meter, Amplus Corp. (1990) Summary page 1.

## Indications for use
The Amplaid AMS50 is a Programmable Admittance Meter which can 1. Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. 2. Perform Acoustic reflex test. 3. Determine acoustic reflex threshold 4. Perform reflex decay test. It 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/K974235
Methodology: https://510kreport.com/methodology