# K111764: Chartis Console

- Pathway: 510(k) (Special)
- Applicant: Pulmonx, Inc.
- Decided: Nov 10, 2011 after 140 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K083199 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083199: Chartis Console, Pulmonx, Inc. (2009) Summary page 1.

## Most influential descendants
- K180011: Pulmonx Chartis Tablet Console (2018), 0 descendants of its own

## Indications for use
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients 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 a re-useable piece of capital equipment that displays the patient information.

Source page: https://510kreport.com/device/K111764
Methodology: https://510kreport.com/methodology