Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Odam — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
613 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972535 | MAGLIFE C | Odam | 1998-01-13 | 189 | 0 |
| K950264 | MAGLIFE | Odam | 1996-09-27 | 613 | 0 |
| K854175 | DEFIGARD 2000 | Odam | 1986-01-13 | 90 | 0 |
| K823934 | CARIEL F12 | Odam | 1983-12-16 | 352 | 0 |
| K823933 | MINIDEF (OR DEFIPORT | Odam | 1983-04-12 | 104 | 0 |
| K823931 | DEFIGARD M(OR DEFISCOPE M | Odam | 1983-04-12 | 104 | 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