510(k) · Cleared
Recalled · Class I · 2016Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Oct 10, 1997 as substantially equivalent to K955564 (Rusch, Inc., 1996) and 1 other predicate after a 366-day review. Its family tree reaches back 2 generations to 1994. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Oct 10, 1997
- Review
- 366 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934465 (1994). 4 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK934465 Dic Tracheostomy Tube and Portex Blue LineSmiths Industries Medical Systems, Inc. · 1994 · Recalled
- 1 generation backK955564 Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996
- This deviceK964056 Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch…Rusch Intl. · 1997
- Descendant · cites it directly · 1 of its ownK122235 Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK982128 Shikani-French Speaking ValvePilling Weck Surgical · 1998
- Descendant · 2 generations on · 0 of its ownK133173 Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK100995 Shikani Speaking ValveShikani Medical, LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013 · cites it directly1descendant
- K982128Shikani-French Speaking ValvePilling Weck Surgical · 1998 · cites it directly1descendant
- K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014 · 2 generations on0descendants
- K100995Shikani Speaking ValveShikani Medical, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934465 | Dic Tracheostomy Tube and Portex Blue Line | Smiths Industries Medical Systems, Inc. | 1994 | 2 |
| −1 | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| 0 (this device) | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… | Rusch Intl. | 1997 | — |
| +1 | K122235 | Rusch Tracflex Plus Tracheostomy Tube Set | Teleflexmedical, Inc. | 2013 | — |
| +1 | K982128 | Shikani-French Speaking Valve | Pilling Weck Surgical | 1998 | — |
| +2 | K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube Set | Teleflexmedical, Inc. | 2014 | — |
| +2 | K100995 | Shikani Speaking Valve | Shikani Medical, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (2)
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 |
|---|---|---|---|
| * | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileSummary page 2…o which the Submitter Claim Equivalence: The subject devices cuffed are substantially equivalent to the Rusch UltraTracheoflex® Tracheostomy Kits legally marketed under K955564. These devices are also similar to the Portex Flexible D.1.C. Tracheostomy Tube found substantially equivalent under K934465. T… | 1996 |
| * | K934465 | Dic Tracheostomy Tube and Portex Blue LineSummary page 2…x® Tracheostomy Kits legally marketed under K955564. These devices are also similar to the Portex Flexible D.1.C. Tracheostomy Tube found substantially equivalent under K934465. The subject devices are similar or equivalent to the predicates in significant features, materials, dimensions, and intended us… | 1994 |
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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2016 | Class I | Z-0044-2017 | Use error | The connector may disconnect from the tracheostomy tube during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122235 (Teleflexmedical, Inc., 2013) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Rusch UltraTracheoflex®/Tracheoflex® Tracheostomy Tube Kits are intended for
use in airway management of tracheostomized patients.
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/K964056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964056
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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