# K945154: BA-Cpas

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Jan 13, 1995 after 84 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
50 later devices descend from it; 5 cite it directly.
0 of 51 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
- K955713: Nobelpharma Bone Anchored Hearing Aid (1996), 45 descendants of its own
- K984162: Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use (1999), 43 descendants of its own
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha) (2002), 40 descendants of its own
- K042017: Baha Divino (2004), 39 descendants of its own
- K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II (1999), 36 descendants of its own

Source page: https://510kreport.com/device/K945154
Methodology: https://510kreport.com/methodology