# K002913: Headband for Baha

- Pathway: 510(k) (Traditional)
- Applicant: Entific Medical Systems, Inc.
- Decided: Oct 17, 2000 after 29 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K250215: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (2025), 0 descendants of its own
- K171088: Cochlear Baha SoundArc (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K002913
Methodology: https://510kreport.com/methodology