Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulmonx, Inc. — 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) |
|---|---|---|---|---|---|
| K111764 | CHARTIS CONSOLE | Pulmonx, Inc. | 2011-11-10 | 140 | 0 |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | Pulmonx, Inc. | 2011-09-29 | 119 | 0 |
| K083199 | CHARTIS CONSOLE | Pulmonx, Inc. | 2009-06-25 | 238 | 0 |
| K083883 | CHARTIS CATHETER | Pulmonx, Inc. | 2009-06-25 | 178 | 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