# K952080: Clarity System II

- Pathway: 510(k) (Traditional)
- Applicant: Sonamed Corp.
- Decided: Sep 19, 1995 after 139 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993177: SABRE (1999), 16 descendants of its own
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), 14 descendants of its own
- K122067: Type 1077 Accuscreen (2012), 9 descendants of its own
- K061744: Cochlea-Scan / Cochlea-Scan Plus (2006), 5 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own

## Recalls of this device
- Jun 4, 2010 · Not classified · Z-2165-2010: There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.

Source page: https://510kreport.com/device/K952080
Methodology: https://510kreport.com/methodology