PULMONX, Corp.
Redwood City, CA, US
PULMONX, Corp. appears in FDA device records in Redwood City, CA. FDA records list 9 510(k) clearances between and , 29 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for PULMONX, Corp. between 1998 and 2026. The busiest year on record is 2009, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2009 | 2 |
| 2011 | 2 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253096 | Chartis Precision Catheter | CBI | Substantially Equivalent | |
| K222340 | Chartis Precision Catheter | CBI | Substantially Equivalent | |
| K212494 | Lung Image Analysis | JAK | Substantially Equivalent | |
| K180011 | Pulmonx Chartis Tablet Console | BZG | Substantially Equivalent | |
| K111764 | CHARTIS CONSOLE | BZG | Substantially Equivalent | |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | CBI | Substantially Equivalent | |
| K083883 | CHARTIS CATHETER | CBI | Substantially Equivalent | |
| K083199 | CHARTIS CONSOLE | BZG | Substantially Equivalent | |
| K973191 | THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM | BTR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007797756 | 3007797756 | PULMONX, Corp. | 700 Chesapeake Drive, Redwood City, CA 94063 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0235-2024 | Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP | Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets PULMONX, Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain