510(k) · Cleared
Recalled · 2005Bivona Hyperflex Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bivona Medical Technologies · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jan 7, 1993 after a 220-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 7, 1993
- Review
- 220 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 5
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK922665 Bivona Hyperflex Tracheostomy TubeBivona Medical Technologies · 1993
- Descendant · cites it directly · 4 of its ownK051587 Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450…Tracoe Medical GmbH · 2005
- Descendant · 2 generations on · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- Descendant · 3 generations on · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · 4 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
- Descendant · 2 generations on · 0 of its ownK203362 TRACOE varioTracoe Medical GmbH · 2021
Most influential descendants
Showing 5 of 5 · See all- K051587Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470Tracoe Medical GmbH · 2005 · cites it directly4descendants
- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · 2 generations on2descendants
- K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · 3 generations on1descendant
- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 4 generations on0descendants
- K203362TRACOE varioTracoe Medical GmbH · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922665 | Bivona Hyperflex Tracheostomy Tube | Bivona Medical Technologies | 1993 | — |
| +1 | K051587 | Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460… | Tracoe Medical GmbH | 2005 | — |
| +2 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +3 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +4 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
| +2 | K203362 | TRACOE vario | Tracoe Medical GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOH device
- #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051587 | Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470 | 2005 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2005 | Not classified | Z-0394-06 | Other | Sterility is compromised by incomplete package seal. |
| Dec 16, 2005 | Not classified | Z-0396-06 | Other | Sterility is compromised by incomplete package seal. |
| Dec 16, 2005 | Not classified | Z-0395-06 | Other | Sterility is compromised by incomplete package seal. |
| Apr 19, 2005 | Not classified | Z-0338-06 | Other | 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 | Other | May have incorrectly printed graduation markings along the tube shaft. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051587 (Tracoe Medical GmbH, 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K922665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922665: Bivona Hyperflex Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922665
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026