Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Odin Medical Technologies , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050237 | STARSHIELD V3 RF TRNT | Odin Medical Technologies , Ltd. | 2005-03-18 | 44 | 0 |
| K032541 | POLESTAR N-20 | Odin Medical Technologies , Ltd. | 2003-09-12 | 25 | 2 |
| K022157 | RF TENT | Odin Medical Technologies , Ltd. | 2002-08-28 | 57 | 0 |
| K020601 | FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL | Odin Medical Technologies , Ltd. | 2002-04-24 | 61 | 0 |
| K010850 | POLESTAR N-10 | Odin Medical Technologies , Ltd. | 2001-12-17 | 271 | 1 |
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