# K914088: Bivona Aire-Cuf (R) Pediatric Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Oct 23, 1991 after 42 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K972546: Rusch Single Use Crystal Tracheostomy Tube Set (1998), 2 descendants of its own
- K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless (2003), 1 descendant of its own
- K133173: Rusch Tracflex Plus Pediatric Tracheostomy Tube Set (2014), 0 descendants of its own

## Recalls of this device
- Aug 28, 2020 · Class II · Z-2946-2020: Label has the incorrect size for the tracheotomy tube.
- Apr 26, 2005 · Not classified · Z-0930-05: The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
- Feb 17, 2005 · Not classified · Z-0302-06: The word PED was printed on the neckflange instead of the word NEO.

Source page: https://510kreport.com/device/K914088
Methodology: https://510kreport.com/methodology