# K923878: Bivona Customized Tracheostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Dec 29, 1992 after 148 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
- Nov 17, 2006 · Not classified · Z-0260-2007: Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

Source page: https://510kreport.com/device/K923878
Methodology: https://510kreport.com/methodology