# K913859: Bivona Fome-Cuf (R) & Air Cuf (R), Modification

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Jan 30, 1992 after 156 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.
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
- Aug 31, 2006 · Not classified · Z-0339-2007: Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
- Aug 11, 2006 · Not classified · Z-0046-2007: The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

Source page: https://510kreport.com/device/K913859
Methodology: https://510kreport.com/methodology