# K914876: Opti-Amp

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Jan 10, 1992 after 73 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052060: Opti-Amp DC-Powered (2005), 2 descendants of its own
- K061443: Smart Usblite, Model M011120 (2006), 1 descendant of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K914876
Methodology: https://510kreport.com/methodology