510(k) · Cleared

Cleared

VisionAir Patient-Specific Airway Stent

K213969510(k) TraditionalCleared Oct 7, 2022291-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

New Cos Inc. Dba Visionair Solutions · NWA Prosthesis, Tracheal, Preformed/Molded

Cleared on Oct 7, 2022 as substantially equivalent to K182743 (New Cos, Inc., 2019) after a 291-day review. Its family tree reaches back 3 generations to 1989.

Decided: Oct 7, 2022
Review: 291 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 deviceK213969 VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions · 2022

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)	K213969	VisionAir Patient-Specific Airway Stent	New Cos Inc. Dba Visionair Solutions	2022	—

FIG. 1 — Lineage of K213969, 1989–2022Source: 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

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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 4 …Device The subject VisionAir Patient-Specific Airway Stent is substantially equivalent to the primary predicate device, Patient-Specific Airway Stent, cleared in 510(k) K182743. Additionally, reference devices, Mimics and Osirix MD, cleared under K073468 and K101342 respectively were used for reference so…	New Cos, Inc.	2019	—
†	K073468	Mimics	Materialise NV	2008	—
†	K101342	Osirix MD	Pixmeo Sarl	2010	—

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 33 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. 2022, 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 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/K213969 · printed Nov 3, 2026

Cite this page

510(k) Report. “K213969: VisionAir Patient-Specific Airway Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213969

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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