Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centrimed Corp. — 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) |
|---|---|---|---|---|---|
| K851613 | CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER | Centrimed Corp. | 1985-06-19 | 61 | 0 |
| K851615 | CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE | Centrimed Corp. | 1985-06-19 | 61 | 0 |
| K851614 | CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY | Centrimed Corp. | 1985-06-19 | 61 | 0 |
| K842007 | CENTRIMED SYSTEM 1 | Centrimed Corp. | 1984-08-03 | 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