Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Totemite Medical Electronics · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Totemite Medical Electronics | 1987-12-29 | 168 | 0 |
| K802900 | HEART SENTINEL | Totemite Medical Electronics | 1981-03-11 | 114 | 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