510(k) · Cleared

Cleared

Tracheobronxane™ Dumon®

K243126510(k) SpecialCleared Oct 29, 202429-day reviewClass II21 CFR 878.3720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novatech SA · NWA Prosthesis, Tracheal, Preformed/Molded

Cleared on Oct 29, 2024 as substantially equivalent to K971509 (Novatech SA, 1997) after a 29-day review. Its family tree reaches back 2 generations to 1989.

Decided: Oct 29, 2024
Review: 29 days
Class: Class II
Product code: NWA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K894380 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK894380 Dumon Tracheobronchial StentBryan Corp. · 1989
1 generation backK971509 EndoxaneNovatech SA · 1997
This deviceK243126 Tracheobronxane™ Dumon®Novatech SA · 2024

View 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)	K243126	Tracheobronxane™ Dumon®	Novatech SA	2024	—

FIG. 1 — Lineage of K243126, 1989–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K971509	Endoxane Summary page 6 …2 3 Predicate Device Device Name: ENDOXANE® Original Applicant: NOVATECH SA 510(k) Number: K971509 Regulation Number: 878.3720 Tracheal Prosthesis Product Code: NWA Device Class:…	Novatech SA	1997	—

Also cleared against K971509: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 35 years and passes through 2 companies; a new generation was cleared every 27.2 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K971509.

How does its category compare?

All NWA devices

NWA Prosthesis, Tracheal, Preformed/Molded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NWA

1in 2024

2007high 1 (2019) · low 0 (2007)2026

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

2007high 2 (2021) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	1
2020	0	—	0
2021	0	—	2
2022	1	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of:

* Tracheobronchial tumors

* Tracheal stenoses with scarring

* Stenoses following surgical anastomosis, resektion or pulmonary transplantation

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/K243126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243126: Tracheobronxane™ Dumon®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243126

Report an extraction error

Are you the manufacturer?

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