510(k) · Cleared
ClearedFome-Cuf and Aire Cuf Tracheostomy Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bivona Medical Technologies · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Jun 18, 1986 after a 5-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 18, 1986
- Review
- 5 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK862267 Fome-Cuf and Aire Cuf Tracheostomy TubesBivona Medical Technologies · 1986
- Descendant · cites it directly · 3 of its ownK961449 Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996
- Descendant · 2 generations on · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · cites it directly · 1 of its ownK031553 Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal…Arcadia Medical Corporation · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996 · cites it directly3descendants
- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · 2 generations on2descendants
- K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · 2 generations on1descendant
- K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric…Arcadia Medical Corporation · 2003 · cites it directly1descendant
- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862267 | Fome-Cuf and Aire Cuf Tracheostomy Tubes | Bivona Medical Technologies | 1986 | — |
| +1 | K961449 | Tracheostomy Tubes Tracoe-Flex | Tracoe Medical GmbH | 1996 | — |
| +2 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +2 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +1 | K031553 | Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and… | Arcadia Medical Corporation | 2003 | 2 |
| +3 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 BTO? 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 BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 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? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K961449 (Tracoe Medical GmbH, 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K862267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862267: Fome-Cuf and Aire Cuf Tracheostomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862267
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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