510(k) · Cleared
Recalled · 2012Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arcadia Medical Corporation · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Nov 18, 2003 as substantially equivalent to K862267 (Bivona Medical Technologies, 1986) and 2 other predicates after a 183-day review. Its family tree reaches back 1 generation to 1986. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 18, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- BTO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K862267 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK862267 Fome-Cuf and Aire Cuf Tracheostomy TubesBivona Medical Technologies · 1986
- This deviceK031553 Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal…Arcadia Medical Corporation · 2003
- Descendant · cites it directly · 0 of its ownK100480 Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation · 2010
Class I recalls in this family
- K912469 Bivona Wire Reinforced Pediatric Tracheostomy Tubedirect predicate · 1991
Most influential descendants
Showing 1 of 1 · See all- K100480Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862267 | Fome-Cuf and Aire Cuf Tracheostomy Tubes | Bivona Medical Technologies | 1986 | — |
| 0 (this device) | K031553 | Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and… | Arcadia Medical Corporation | 2003 | — |
| +1 | K100480 | Rota-Trach Tracheostomy Tube Model Rota-Trach | Vitaltec Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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.
1 device in this family has 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 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862267 | Fome-Cuf and Aire Cuf Tracheostomy TubesSummary page 1…NNECTOR) Predicate Device: Bivona Medical Technologies - Fome-Cuf and Aire Cuf Tracheostomy Tubes K862267 Aire Cuf Adjustable K8946 14 Pediatric Tra… | 1986 |
| * | K894614 | Bivona Aire-Cuf Adjustable Tracheostomy TubeSummary page 1…Fome-Cuf and Aire Cuf Tracheostomy Tubes K862267 Aire Cuf Adjustable K8946 14 Pediatric Trach Tube K9 12469 Intended Use: Tracheostomy tubes are intended fo… | 1989 |
| * | K912469 | Bivona Wire Reinforced Pediatric Tracheostomy TubeSummary page 1…K862267 Aire Cuf Adjustable K8946 14 Pediatric Trach Tube K9 12469 Intended Use: Tracheostomy tubes are intended for use in providing direct tracheal access for airway management. === Page 2 ==… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100480 | Rota-Trach Tracheostomy Tube Model Rota-Trach | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2012 | Not classified | Z-1628-2012 | Process control | A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula. |
| May 8, 2011 | Not classified | Z-2657-2011 | Process control | The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction… |
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.
- K912469Bivona Wire Reinforced Pediatric Tracheostomy TubeBivona Medical Technologies · 1991 · Direct predicate · ◆ in the 1991 ancestors bar of FIG. 128 Class I recalls
What does this lineage say?
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 | — |
What is it indicated for?
Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031553: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031553
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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