510(k) · Cleared
Recalled · Class II · 2020Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Sep 12, 2008 after a 113-day review. The FDA summary names no predicate by number. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 12, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK081440 Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy TubesSmiths Medical Asd, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK083641 Bivona Tracheostomy TubesSmiths Medical Asd, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK122531 Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · Recalled (Class I)
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K083641Bivona Tracheostomy TubesSmiths Medical Asd, Inc. · 2009 · cites it directly7descendants
- K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…Covidien · 2012 · 2 generations on2descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081440 | Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2008 | — |
| +1 | K083641 | Bivona Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2009 | 3 |
| +2 | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube… | Covidien | 2012 | Class I |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083641 | Bivona Tracheostomy Tubes | 2009 | 7 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2020 | Class II | Z-2485-2020 | Process control | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K083641 (Smiths Medical Asd, Inc., 2009) has gone furthest, with 7 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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
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…
Read the full statement (201 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081440: Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081440
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026