510(k) Report

FDA applicant

Pulmonx Corporation

Redwood City, CA10 decisions1998–20261 recall

FDA records 10 decisions for Pulmonx Corporation (Redwood City, CA) from 1998 to 2026: 9 510(k) clearances and 1 original PMA approval. Most are in product codes CBI (Tube, Tracheal/Bronchial, Differential…) and BZG (Spirometer, Diagnostic). Its devices cite 7 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Pulmonx, Inc.”, “Pulmonx”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Pulmonx Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2009: 22011: 22018: 22021: 12022: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pulmonx Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pulmonx Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)4decisions
  • BZGSpirometer, Diagnostic3decisions
  • BTRTube, Tracheal (W/Wo Connector)1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • NJKValve, Pulmonary1decision

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083199Chartis ConsolePulmonx, Inc. · 20091cites it
  • K222340Chartis Precision CatheterPulmonx Corporation · 20221cites it
  • K973191The Visualized Endotracheal Tube System or Vett SystemPulmonx · 19981cites it
  • K111764Chartis ConsolePulmonx, Inc. · 20111cites it
  • K083883Chartis CatheterPulmonx, Inc. · 20091cites it
  • K111522Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 20111cites it

What has FDA decided for it lately?

  • K253096Chartis Precision CatheterPulmonx Corporation · 2026
  • K222340Chartis Precision CatheterPulmonx Corporation · 2022
  • K212494Lung Image AnalysisPulmonx Corporation · 2021
  • K180011Pulmonx Chartis Tablet ConsolePulmonx Corporation · 2018
  • P180002Zephyr Endobronchial Valve SystemPulmonx Corporation · 20181 recall
  • K111764Chartis ConsolePulmonx, Inc. · 2011
  • K111522Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc. · 2011
  • K083199Chartis ConsolePulmonx, Inc. · 2009

All 5 as Pulmonx Corporation →All 4 as Pulmonx, Inc. →The one decision as Pulmonx →

What has been recalled?

1 recall linked to its devices; the latest:

  • P180002Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LPAug 31, 2023Class II