510(k) · Cleared
ClearedPatient-Specific Airway Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Cos, Inc. · NWA Prosthesis, Tracheal, Preformed/Molded
Cleared on Oct 23, 2019 as substantially equivalent to K971509 (Novatech SA, 1997) after a 390-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Oct 23, 2019
- Review
- 390 days
- Class
- Class II
- Product code
- NWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894380 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK894380 Dumon Tracheobronchial StentBryan Corp. · 1989
- 1 generation backK971509 EndoxaneNovatech SA · 1997
- This deviceK182743 Patient-Specific Airway StentNew Cos, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK261541 VisionAir Enhanced Stock StentVisionAir Solutions · 2026
- Descendant · cites it directly · 0 of its ownK213969 VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894380 | Dumon Tracheobronchial Stent | Bryan Corp. | 1989 | — |
| −1 | K971509 | Endoxane | Novatech SA | 1997 | — |
| 0 (this device) | K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019 | — |
| +1 | K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | 2026 | — |
| +1 | K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 NWA? 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 NWA device
- #1 K261541 VisionAir Enhanced Stock Stentscore 12.0 · 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 |
|---|---|---|---|
| * | K971509 | EndoxaneSummary page 4…: Subject Device: Patient-Specific Airway Corresponding Predicate Device(s) Stent Patient-Specific Airway Stent K971509: ENDOXANE REFERENCE DEVICES: Device 510(k) Number Device Name Reason for Use… | 1997 |
| † | K073468 | Mimics | 2008 |
| † | K894380 | Dumon Tracheobronchial Stent | 1989 |
| † | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 22.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K261541 (VisionAir Solutions, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K971509.
How does its category compare?
All NWA devicesNWA Prosthesis, Tracheal, Preformed/Molded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NWA
Too few NWA 510(k)s in any year since 2007 to give a median.
Recalls per year · NWA
No recall names NWA since 2007.
Adverse event reports per year · NWA
2in 2021
MAUDE reports naming product code NWA, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182743 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182743: Patient-Specific Airway Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182743
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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