Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ocg Technology, Inc. — 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) |
|---|---|---|---|---|---|
| K862947 | THE EXPERT MODELS RTS 2000 AND RTS 2000H | Ocg Technology, Inc. | 1987-11-04 | 456 | 0 |
| K863153 | MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH | Ocg Technology, Inc. | 1987-01-06 | 144 | 0 |
| K812971 | CARDIOINTEGRAM | Ocg Technology, Inc. | 1981-12-29 | 68 | 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