# K222340: Chartis Precision Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonx Corporation
- Decided: Dec 1, 2022 after 120 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894337 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111522: Chartis Catheter Model CHR-CA-12.0, Pulmonx, Inc. (2011) Summary page 4.

## Most influential descendants
- K253096: Chartis Precision Catheter (2026), 0 descendants of its own

## Indications for use
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is capital equipment that is reusable and displays the patient information.

Source page: https://510kreport.com/device/K222340
Methodology: https://510kreport.com/methodology