Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sitco, 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) |
|---|---|---|---|---|---|
| K990192 | BIOPSY-DIGIT | Sitco, Inc. | 1999-03-12 | 50 | 0 |
| K982049 | BIOPSY M | Sitco, Inc. | 1998-07-14 | 33 | 0 |
| K973856 | GIOTTO HT | Sitco, Inc. | 1997-11-21 | 43 | 0 |
| K953255 | NUQUEST NUCLEAR MEDICINE COMPUTER | Sitco, Inc. | 1995-10-24 | 104 | 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