Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sigma Intl. — 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) |
|---|---|---|---|---|---|
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY | Sigma Intl. | 2004-08-26 | 20 | 13 |
| K962709 | SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER | Sigma Intl. | 1996-10-07 | 87 | 0 |
| K942162 | SIGMA 8000 AND SIGMA 8002 | Sigma Intl. | 1994-10-20 | 169 | 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