# K894614: Bivona Aire-Cuf Adjustable Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Oct 13, 1989 after 85 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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.
2 later devices descend from it; 1 cites 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
- K031553: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes (2003), 1 descendant of its own
- K100480: Rota-Trach Tracheostomy Tube Model Rota-Trach (2010), 0 descendants of its own

## Recalls of this device
- Jul 25, 2005 · Not classified · Z-0301-06: Instructions for use included in the package are for a different tracheostomy tube.
- Feb 20, 2003 · Not classified · Z-0927-03: May have incorrectly printed graduation markings along the tube shaft.

Source page: https://510kreport.com/device/K894614
Methodology: https://510kreport.com/methodology