# K971747: Amplaid 460

- Pathway: 510(k) (Traditional)
- Applicant: Amplifon S.P.A.
- Decided: Aug 5, 1997 after 85 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- 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 K880059 (1988). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880059: Amplaid 309 Clinical Audiometer, Amplus Corp. (1988) Summary page 1.

## Most influential descendants
- K983915: Amplaid A315 and A319 (1999), 0 descendants of its own
- K983712: Amplaid A311 Series (1999), 0 descendants of its own

## Indications for use
The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Source page: https://510kreport.com/device/K971747
Methodology: https://510kreport.com/methodology