# K935701: Viennatone an, Viennatone as Fidelity F228, Fidelity F229

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: May 10, 1994 after 161 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon (2012), 3 descendants of its own
- K172460: ADHEAR System (2018), 1 descendant of its own
- K260452: Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) (2026), 0 descendants of its own
- K261256: Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K935701
Methodology: https://510kreport.com/methodology