Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boule Medical AB — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083420 | MEDONIC M SERIES | Boule Medical AB | 2009-02-03 | 76 | 0 |
| K032214 | MEDONIC CA620/530 HEMATOLOGY ANALYZER | Boule Medical AB | 2004-01-29 | 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