# K922665: Bivona Hyperflex Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Jan 7, 1993 after 220 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices 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.

## Most influential descendants
- K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470 (2005), 4 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
- K203362: TRACOE vario (2021), 0 descendants of its own

## Recalls of this device
- Dec 16, 2005 · Not classified · Z-0394-06: Sterility is compromised by incomplete package seal.
- Dec 16, 2005 · Not classified · Z-0396-06: Sterility is compromised by incomplete package seal.
- Dec 16, 2005 · Not classified · Z-0395-06: Sterility is compromised by incomplete package seal.
- Apr 19, 2005 · Not classified · Z-0338-06: The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
- Feb 20, 2003 · Not classified · Z-0927-03: May have incorrectly printed graduation markings along the tube shaft.

Source page: https://510kreport.com/device/K922665
Methodology: https://510kreport.com/methodology