510(k) · Cleared
Recalled · 2004Shiley Flextra Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Nov 14, 2003 as substantially equivalent to K003315 (Mallinckrodt, Inc., 2000) and 5 other predicates after a 247-day review. Its family tree reaches back 2 generations to 1979. 1 of the 15 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Nov 14, 2003
- Review
- 247 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 2 generations to K792222 (1979). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
- 1 generation backK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
- This deviceK030787 Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. · 2003
Class I recalls in this family
- K962173 Shikey Tracheostomy Tubes and Accessoriesdirect predicate · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792222 | Shiley Low Pressure Thin-Cuffed Trach. | Shiley, Inc. | 1979 | — |
| −1 | K962173 | Shikey Tracheostomy Tubes and Accessories | Mallinckrodt Medical | 1996 | Class I |
| 0 (this device) | K030787 | Shiley Flextra Tracheostomy Tube | Nellcor Puritan Bennett, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 4 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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? (6)
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 |
|---|---|---|---|
| * | K003315 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula | 2000 |
| * | K962173 | Shikey Tracheostomy Tubes and AccessoriesSummary page 1…ft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt Inc., KO033 15 2. Shiley Tracheostomy Tubes and Accessories, Mallinckrodt Medical, K962 173 3. Shiley Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure / Lower Profile Cuff and Disposable Inner Cannula, Mal… | 1996 |
| * | K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…Summary page 1…edical, K962 173 3. Shiley Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure / Lower Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical Inc., K963732 4. Modified Shiley Low Pressure Cuffed Tracheostomy Tube, Shiley Inc., K880247 5. Shiley Disposable Cannula Tracheostomy Tube wit… | 1997 |
| * | K880247 | Modified Shiley Low Pressure Cuffed Tracheo. TubesSummary page 1…Pressure / Lower Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical Inc., K963732 4. Modified Shiley Low Pressure Cuffed Tracheostomy Tube, Shiley Inc., K880247 5. Shiley Disposable Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula, Shiley Inc., K8 11447 6. S… | 1988 |
| * | K811447 | Shiley Disposable Cannula Trach. TubeSummary page 1…essure Cuffed Tracheostomy Tube, Shiley Inc., K880247 5. Shiley Disposable Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula, Shiley Inc., K8 11447 6. Shiley Cuffed Single Cannula SCT Tracheostomy Tubes, Shiley Inc., K810106 DEVICEDESCRIPTION The Shiley FlexTra disposable tr… | 1981 |
| * | K810106 | Shiley Single Cannula Tracheostomy TubeSummary page 1…nula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula, Shiley Inc., K8 11447 6. Shiley Cuffed Single Cannula SCT Tracheostomy Tubes, Shiley Inc., K810106 DEVICEDESCRIPTION The Shiley FlexTra disposable tracheostomy tubes are double cannula tracheostomy tubes with disposable inner… | 1981 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2004 | Not classified | Z-0721-05 | Other | Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury. |
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.
- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 6 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K003315.
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 Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.
Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030787: Shiley Flextra Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030787
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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