Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remco Italia S.P.A. · 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) |
|---|---|---|---|---|---|
| K032200 | ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH | Remco Italia S.P.A. | 2003-10-03 | 77 | 0 |
| K032276 | CLICK HOLTER | Remco Italia S.P.A. | 2003-08-27 | 35 | 0 |
| K852770 | CARIOLINE(ELECTROCARDIOGRAPH) | Remco Italia S.P.A. | 1985-08-01 | 34 | 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