Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sangstat Medical Corp. · 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) |
|---|---|---|---|---|---|
| K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEART | Sangstat Medical Corp. | 1999-08-05 | 90 | 1 |
| K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI- | Sangstat Medical Corp. | 1998-09-30 | 400 | 0 |
| K980109 | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | Sangstat Medical Corp. | 1998-08-18 | 218 | 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