ClearanceBrief
Company ยท US

Pulmonx, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)4
BZGSpirometer, Diagnostic3
BTRTube, Tracheal (W/Wo Connector)1
JAKSystem, X-Ray, Tomography, Computed1
NJKValve, Pulmonary1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 13, 2026K253096Chartis Precision Catheter
Pulmonx Corporation
CBI
Dec 1, 2022K222340Chartis Precision Catheter
Pulmonx Corporation
CBI
Sep 2, 2021K212494Lung Image Analysis
Pulmonx Corporation
JAK
Jul 13, 2018K180011Pulmonx Chartis Tablet Console
Pulmonx Corporation
BZG
Nov 10, 2011K111764CHARTIS CONSOLE
Pulmonx, Inc.
BZG
Sep 29, 2011K111522CHARTIS CATHETER MODEL CHR-CA-12.0
Pulmonx, Inc.
CBI
Jun 25, 2009K083883CHARTIS CATHETER
Pulmonx, Inc.
CBI
Jun 25, 2009K083199CHARTIS CONSOLE
Pulmonx, Inc.
BZG
Feb 13, 1998K973191THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
Pulmonx
BTR

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 6, 2023Pulmonx, Corp.
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Open, Classified		 NJKNone listed
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