510(k) · Cleared
ClearedRusch Polyflex Stent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · NYT Prosthesis, Tracheal, Expandable, Polymeric
Cleared on Nov 27, 2001 after a 57-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Nov 27, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- NYT
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK013266 Rusch Polyflex Stent KitRusch Intl. · 2001
- Descendant · cites it directly · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · cites it directly15descendants
- K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007 · cites it directly14descendants
- K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · cites it directly11descendants
- K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · cites it directly6descendants
- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013266 | Rusch Polyflex Stent Kit | Rusch Intl. | 2001 | — |
| +1 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| +1 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| +1 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| +1 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| +2 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 NYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Boston Scientific Ultraflex Named without a submission number | |
| * | — | Schneider Wall Stent Named without a submission number | |
| * | — | Cook Gianturco-Wallace Tracheobronchial “Z” Stent Named without a submission number | |
| * | — | Bryan Dumon Tracheal Bronchial Stent Named without a submission number | |
| * | — | Hood Tracheal Bronchial Stent Named without a submission number | |
| * | — | Hood Westaby Stent Named without a submission number |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033053 (Alveolus, Inc., 2004) has gone furthest, with 15 descendants of its own.
How does its category compare?
All NYT devicesNYT Prosthesis, Tracheal, Expandable, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NYT
FDA has decided no NYT device since 2007.
Median 510(k) review, days · NYT
Too few NYT 510(k)s in any year since 2007 to give a median.
Recalls per year · NYT
No recall names NYT since 2007.
Adverse event reports per year · NYT
1in 2024
MAUDE reports naming product code NYT, 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 | 0 | — | 0 | 12 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Compression or strictures due to tumors (trachea and main bronchus)
Stenosis of the central airways (such as trachea and main bronchus)
Tracheo Esophageal fistula
Airway complications such as-anastomosis and stenosis
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/K013266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013266: Rusch Polyflex Stent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026