510(k) · Cleared
Recalled · 2011Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless
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 Mar 28, 2003 as substantially equivalent to K972546 (Rusch Intl., 1998) after a 123-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 28, 2003
- Review
- 123 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913270 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK913270 Bivona Fome-Cuf (R) Pediatric Tracheostomy TubeBivona Medical Technologies · 1991
- 1 generation backK972546 Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl. · 1998
- This deviceK023918 Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 2003
- Descendant · cites it directly · 0 of its ownK133173 Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913270 | Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube | Bivona Medical Technologies | 1991 | — |
| −1 | K972546 | Rusch Single Use Crystal Tracheostomy Tube Set | Rusch Intl. | 1998 | — |
| 0 (this device) | K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless | Rusch Intl. | 2003 | — |
| +1 | K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube Set | Teleflexmedical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K972546 | Rusch Single Use Crystal Tracheostomy Tube SetSummary page 1…al Clear Tracheostomy Sets are substantially equivalent in design and materials to: Rusch Crystal Tracheostomy Set - K972546 Page 2 4. D e s c r i p t i o n of t h e D e v i c e : TracheoFix Sets will be offered in two (2) v… | 1998 |
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 |
|---|---|---|---|
| K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube Set | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2011 | Not classified | Z-2695-2011 | Other | Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention. |
| Apr 4, 2011 | Not classified | Z-2697-2011 | Other | Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K133173 (Teleflexmedical, Inc., 2014) has gone furthest, with 0 descendants 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 Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023918: Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023918
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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