Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syncor Pharmaceuticals, 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) |
|---|---|---|---|---|---|
| K994018 | PHARMASEED, MODEL BT-125-3 | Syncor Pharmaceuticals, Inc. | 2000-07-17 | 234 | 0 |
| K994016 | PHARMASEED, MODEL BT-103-3 | Syncor Pharmaceuticals, Inc. | 2000-07-14 | 231 | 0 |
| K992007 | PHARMASEED, MODEL BT-103-1 | Syncor Pharmaceuticals, Inc. | 2000-01-14 | 213 | 0 |
| K992008 | PHARMASEED, MODEL BT-125-1 | Syncor Pharmaceuticals, Inc. | 1999-12-23 | 191 | 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