# K792035: Fome-Cuf-Wire RE-Enforced, Aire-Cuf Wire

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Oct 26, 1979 after 16 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K060094: Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes (2006), 0 descendants of its own

## Recalls of this device
- Aug 9, 2021 · Class II · Z-0177-2022: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
- Aug 9, 2021 · Class II · Z-0178-2022: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Source page: https://510kreport.com/device/K792035
Methodology: https://510kreport.com/methodology