Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Triad Medical Division · 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) |
|---|---|---|---|---|---|
| K840391 | ANGIOGRAPHIC PROCEDURE TRAY | Triad Medical Division | 1984-08-27 | 210 | 0 |
| K831287 | E-Z FIT | Triad Medical Division | 1983-10-14 | 177 | 0 |
| K823054 | DRAPE, SURGICAL ANGIOGRAPHY | Triad Medical Division | 1983-01-12 | 86 | 0 |
| K812964 | INTRODUCER, PERCUTANEOUS SELDINGER | Triad Medical Division | 1981-11-16 | 25 | 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