510(k) · Cleared
ClearedShiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jun 1, 2020 as substantially equivalent to K173384 (Smiths Medical Ads, Inc., 2018) and 1 other predicate after a 209-day review. Its family tree reaches back 5 generations to 1990. 4 of the 25 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 1, 2020
- Review
- 209 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903730 (1990). 24 ancestors in all, the oldest K792222 (1979). No later device cites it as a predicate yet. 4 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 4 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 3 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 2 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 1 generation backK173384 BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont…Smiths Medical Ads, Inc. · 2018 · Recalled (Class I)
- This deviceK193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −4 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −3 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −2 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −1 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect… | Smiths Medical Ads, Inc. | 2018 | Class I |
| 0 (this device) | K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 4 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 1 |
| 1997 | 2 | 0 |
| 2015 | 2 | 2 |
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.
4 devices in this family have 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 |
|---|---|---|---|
| * | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…Summary page 4…JOH, BTO III Predicate Devices Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube (K173384) Shiley™ Adult Flexible Tracheostomy Tube Cuffless… | 2018 |
| * | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Summary page 4…Tracheostomy Tube Cuffless or with TaperGuard™ Cuff, Reusable Inner Cannula (RIC) (K150844) Reference Devices Portex Blue Line Ultra Suctionaid Tracheostomy… | 2015 |
| † | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | 2003 |
| † | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult… | 2015 |
| † | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 2018 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy…Covidien · 2015 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible…Covidien · 2015 · 2 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 9 of the 24 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K173384.
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. 2020, 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?
Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193077: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193077
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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