# K894613: Bivona Fome-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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Feb 20, 2003 · Not classified · Z-0927-03: May have incorrectly printed graduation markings along the tube shaft.

Source page: https://510kreport.com/device/K894613
Methodology: https://510kreport.com/methodology