Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scion International, Inc. · 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) |
|---|---|---|---|---|---|
| K040087 | RABBIT | Scion International, Inc. | 2004-04-01 | 76 | 0 |
| K973698 | SCION BALLOON ELEVATOR | Scion International, Inc. | 1998-03-31 | 186 | 0 |
| K973652 | DUOCLIPPER TITANIUM CLIPS | Scion International, Inc. | 1998-03-27 | 183 | 0 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 | 49 | 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