# K912967: Bivona Aire-Cuf Tracheostomy Tube W/Talk Attach.

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Jul 17, 1991 after 9 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
2 of 23 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
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K173384: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (2018), 4 descendants of its own

Source page: https://510kreport.com/device/K912967
Methodology: https://510kreport.com/methodology