Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scole Engineering Co. — 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) |
|---|---|---|---|---|---|
| K923664 | SCOLE 300 ECG RECORDER | Scole Engineering Co. | 1994-01-13 | 540 | 0 |
| K822362 | ALTA II ECG RECORDER | Scole Engineering Co. | 1983-01-14 | 161 | 0 |
| K822363 | ALTA III ECG RECORDER | Scole Engineering Co. | 1982-10-04 | 59 | 0 |
| K770829 | RECORDING UNIT, MODEL 1445 | Scole Engineering Co. | 1977-05-18 | 13 | 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