Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulmone Advanced Medical Devices, Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 | 165 | 0 |
| K141793 | PULMONE MINIBOXPFT 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015-03-06 | 247 | 0 |
| K133051 | PULMONE MINIBOX PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014-05-02 | 217 | 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