Cleared Traditional

K253096 - Chartis Precision Catheter (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253096 · Pulmonx Corporation · Anesthesiology device
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Feb 2026
Decision
143d
Days
Class 2
Risk

K253096 is an FDA 510(k) clearance for the Chartis Precision Catheter. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Pulmonx Corporation (Redwood City, US). The FDA issued a Cleared decision on February 13, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pulmonx Corporation devices

Submission Details

510(k) Number K253096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date February 13, 2026
Days to Decision 143 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 139d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 33
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K253096.
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Chartis Precision Catheter
K222340 · Pulmonx Corporation · Dec 2022
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