510(k) · Cleared

Cleared

VisionAir Enhanced Stock Stent

K261541510(k) SpecialCleared Jun 1, 202624-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

VisionAir Solutions · NWA Prosthesis, Tracheal, Preformed/Molded

Cleared on Jun 1, 2026 as substantially equivalent to K182743 (New Cos, Inc., 2019) after a 24-day review. Its family tree reaches back 3 generations to 1989.

Decided: Jun 1, 2026
Review: 24 days
Class: Class II
Product code: NWA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K894380 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK894380 Dumon Tracheobronchial StentBryan Corp. · 1989
2 generations backK971509 EndoxaneNovatech SA · 1997
1 generation backK182743 Patient-Specific Airway StentNew Cos, Inc. · 2019
This deviceK261541 VisionAir Enhanced Stock StentVisionAir Solutions · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K894380	Dumon Tracheobronchial Stent	Bryan Corp.	1989	—
−2	K971509	Endoxane	Novatech SA	1997	—
−1	K182743	Patient-Specific Airway Stent	New Cos, Inc.	2019	—
0 (this device)	K261541	VisionAir Enhanced Stock Stent	VisionAir Solutions	2026	—

FIG. 1 — Lineage of K261541, 1989–2026Source: 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 K243126 Tracheobronxane™ Dumon®score 8.6 · 2 generations · no Class I recall
#2 Held for the reportin the report

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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
*	K182743	Patient-Specific Airway Stent Summary page 5 …Predicate Device 510(k) Number VisionAir Solutions Patient-Specific Stent K182743 1 Premarket Notification: Tracheal Prosthesi…	New Cos, Inc.	2019	—

Also cleared against K182743: 1 other device →

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 37 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K182743.

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. 2026, 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?

The VisionAir Enhanced Stock Stent is indicated for the treatment of adults 222 years of age with symptomatic stenosis of the airway. The Enhanced Stock 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K261541 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261541: VisionAir Enhanced Stock Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261541

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026