Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Segami Corporation · 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) |
|---|---|---|---|---|---|
| K071584 | OASIS RELEASE 1.0 | Segami Corporation | 2007-08-31 | 81 | 0 |
| K070397 | DGSCOPE, RELEASE 1.0 | Segami Corporation | 2007-04-13 | 60 | 0 |
| K070683 | MIRAGE CEDARS OPTION | Segami Corporation | 2007-04-12 | 31 | 0 |
| K043441 | MIRAGE, RELEASE 5.5 | Segami Corporation | 2005-01-13 | 30 | 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