510(k) · Cleared
ClearedRusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jun 28, 1996 as substantially equivalent to K934465 (Smiths Industries Medical Systems, Inc., 1994) after a 205-day review. Its family tree reaches back 1 generation to 1994. 1 of the 7 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 205 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934465 (1994). 5 later devices descend from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK934465 Dic Tracheostomy Tube and Portex Blue LineSmiths Industries Medical Systems, Inc. · 1994 · Recalled
- This deviceK955564 Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK964056 Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch…Rusch Intl. · 1997 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK122235 Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK982128 Shikani-French Speaking ValvePilling Weck Surgical · 1998
- Descendant · 3 generations on · 0 of its ownK133173 Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK100995 Shikani Speaking ValveShikani Medical, LLC · 2010
Class I recalls in this family
- K964056 Rusch Ultra Tracheoflex Fenestrated Kit…cites it directly · 1997
Most influential descendants
Showing 5 of 5 · See all- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy…Rusch Intl. · 1997 · cites it directly4descendants
- K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc. · 2013 · 2 generations on1descendant
- K982128Shikani-French Speaking ValvePilling Weck Surgical · 1998 · 2 generations on1descendant
- K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014 · 3 generations on0descendants
- K100995Shikani Speaking ValveShikani Medical, LLC · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934465 | Dic Tracheostomy Tube and Portex Blue Line | Smiths Industries Medical Systems, Inc. | 1994 | 2 |
| 0 (this device) | K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| +1 | K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… | Rusch Intl. | 1997 | Class I |
| +2 | K122235 | Rusch Tracflex Plus Tracheostomy Tube Set | Teleflexmedical, Inc. | 2013 | — |
| +2 | K982128 | Shikani-French Speaking Valve | Pilling Weck Surgical | 1998 | — |
| +3 | K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube Set | Teleflexmedical, Inc. | 2014 | — |
| +3 | K100995 | Shikani Speaking Valve | Shikani Medical, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 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? (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 |
|---|---|---|---|
| * | K934465 | Dic Tracheostomy Tube and Portex Blue LineSummary page 2…acheoflex’ Tracheotomy Set, available since April 1971. This device is also similar to the Portex Flexible D.I.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 |
| * | — | Safetyflex Tracheotomy Set Named without a submission number | |
| * | — | Tracheoflex Tracheotomy Set Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964056 | Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy… Class I | 1997 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Risch Ultra Tracheoflex” Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
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/K955564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955564: Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955564
Report an extraction error
Are you the manufacturer?
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