# K081440: Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Sep 12, 2008 after 113 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.
8 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K083641: Bivona Tracheostomy Tubes (2009), 7 descendants of its own
- K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T (2012), 2 descendants of its own
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own

## Recalls of this device
- May 26, 2020 · Class II · Z-2485-2020: One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

## Indications for use
The Bivona® Fixed Neckflange Hyperflex TM Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes. The Bivona® Adjustable Neckflange Hyperflex TM Tracheostomy Tube is not intended for long term use. It is intended to provide temporary airway access for a tracheostomized patient when determining the optimal tube length for a patient. It must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined. The Bivona® Adjustable and Fixed Neckflange Hyperflex TM Tracheostomy Tubes with wire reinforcement have been determined to be MR-conditional. They may be used in a static magnetic field of 3-Tesla or less with spatial gradient magnetic field of 720-Gauss/cm or less and maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning. The Bivona® Adjustable and Fixed Neckflange Hyperflex TM Tracheostomy Tubes are contraindicated for use with lasers or electrosurgical devices where their output may contact and damage the tube. The Bivona® Adjustable Neckflange Hyperflex TM Tracheostomy Tube is contraindicated for use in home care settings.

Source page: https://510kreport.com/device/K081440
Methodology: https://510kreport.com/methodology