Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iei Technology Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101796 | PACSMATE MMD-5201M MONITOR | Iei Technology Corp. | 2010-07-15 | 17 | 0 |
| K091687 | PACSMATE, MODEL MMD-4300C/MMD-4300CX | Iei Technology Corp. | 2009-07-07 | 27 | 0 |
| K082496 | PACSMATE MMD-3213M MONITOR | Iei Technology Corp. | 2008-09-09 | 11 | 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