Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oceanic Medical Products, 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) |
|---|---|---|---|---|---|
| K072420 | MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE | Oceanic Medical Products, Inc. | 2008-01-22 | 147 | 0 |
| K060193 | MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 | Oceanic Medical Products, Inc. | 2006-04-10 | 75 | 0 |
| K010613 | MAGELLAN-2200, MODEL 1 | Oceanic Medical Products, Inc. | 2001-10-12 | 225 | 0 |
| K002951 | MAGELLAN VENTILATOR | Oceanic Medical Products, Inc. | 2000-12-08 | 78 | 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