510(k) · Cleared
ClearedBivona Fome-Cuf (R) Pediatric 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 Aug 9, 1991 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 9, 1991
- Review
- 17 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK913270 Bivona Fome-Cuf (R) Pediatric Tracheostomy TubeBivona Medical Technologies · 1991
- Descendant · cites it directly · 2 of its ownK972546 Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998
- Descendant · 2 generations on · 1 of its ownK023918 Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK133173 Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K972546Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998 · cites it directly2descendants
- K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 2003 · 2 generations on1descendant
- K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913270 | Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube | Bivona Medical Technologies | 1991 | — |
| +1 | K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | Rusch Intl. | 1998 | — |
| +2 | K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless | Rusch Intl. | 2003 | 2 |
| +3 | K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube Set | Teleflexmedical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | 1998 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972546 (Rusch Intl., 1998) has gone furthest, with 2 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/K913270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913270: Bivona Fome-Cuf (R) Pediatric 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/K913270
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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