510(k) · Cleared
ClearedTRACOE vario
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tracoe Medical GmbH · JOH Tube Tracheostomy And Tube Cuff
Cleared on Aug 5, 2021 as substantially equivalent to K051587 (Tracoe Medical GmbH, 2005) after a 262-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 5, 2021
- Review
- 262 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922665 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
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? (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 |
|---|---|---|---|
| * | K051587 | Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470Summary page 4…w: Manufacturer Device 510(k) # TRACOE medical GmbH vario Tracheostomy Tubes K051587 Device Description: TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access to the a… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 15.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K051587.
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. 2021, 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?
TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to
those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.
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/K203362 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203362: TRACOE vario.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203362
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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