510(k) · Cleared
ClearedTracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tracoe Medical GmbH · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Oct 25, 2005 as substantially equivalent to K922665 (Bivona Medical Technologies, 1993) after a 132-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Oct 25, 2005
- Review
- 132 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922665 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922665 Bivona Hyperflex Tracheostomy TubeBivona Medical Technologies · 1993 · Recalled
- This deviceK051587 Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450…Tracoe Medical GmbH · 2005
- Descendant · cites it directly · 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 · 3 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
- Descendant · cites it directly · 0 of its ownK203362 TRACOE varioTracoe Medical GmbH · 2021
Most influential descendants
Showing 4 of 4 · See all- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · cites it directly2descendants
- K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · 2 generations on1descendant
- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 3 generations on0descendants
- K203362TRACOE varioTracoe Medical GmbH · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922665 | Bivona Hyperflex Tracheostomy Tube | Bivona Medical Technologies | 1993 | 5 |
| 0 (this device) | K051587 | Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460… | Tracoe Medical GmbH | 2005 | — |
| +1 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +2 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +3 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
| +1 | K203362 | TRACOE vario | Tracoe Medical GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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? (1)
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 |
|---|---|---|---|
| * | K922665 | Bivona Hyperflex Tracheostomy TubeSummary page 3…Vario Tracheostomy Tubes are indicated for providing tracheal access for management to those patients with unusual anatomy or thick neck patients. (Ref Predicate 510(k)-K922665- Bivona TTS Adjustable Neck Flange Tracheostomy Tube) Prescription Use: X AND/OR Over -The… | 1993 |
What descends from it? (4)
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?
- Its one ancestor has a recall.
- Of its descendants, K120079 (Primed Halberstadt Medizintechnik GmbH, 2012) has gone furthest, with 2 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 | — |
What is it indicated for?
TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management to those patients with unusual anatomy or thick neck patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051587
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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