Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulmonx Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | 2026-02-13 | 143 | 0 |
| K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022-12-01 | 120 | 0 |
| K212494 | Lung Image Analysis | Pulmonx Corporation | 2021-09-02 | 24 | 0 |
| K180011 | Pulmonx Chartis Tablet Console | Pulmonx Corporation | 2018-07-13 | 192 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda