Cleared Traditional

Chartis Precision Catheter

K253096 · Pulmonx Corporation · Anesthesiology

Feb 2026

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K253096 is an FDA 510(k) clearance for the Chartis Precision Catheter, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Pulmonx Corporation (Redwood Citry, US). The FDA issued a Cleared decision on February 13, 2026, 143 days after receiving the submission on September 23, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K253096 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740