# K944178: Bivona Flextend Pediatric & Neonatal Tracheostromy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Oct 27, 1994 after 62 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
- Jan 18, 2021 · Class II · Z-1145-2021: Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly pac
- Dec 15, 2020 · Class II · Z-0726-2021: A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Source page: https://510kreport.com/device/K944178
Methodology: https://510kreport.com/methodology