Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sigma — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
20 daysmedian FDA review time
265 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962239 | SMART ADJUSTER (SA201) | Sigma | 1997-01-10 | 213 | 0 |
| K926191 | SIGMA 7000 AND SIGMA70002 | Sigma | 1993-08-31 | 265 | 0 |
| K851738 | MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & | Sigma | 1985-05-15 | 20 | 0 |
| K851737 | MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & | Sigma | 1985-05-15 | 20 | 0 |
| K820038 | SIGMA 7000 | Sigma | 1983-01-26 | 19 | 0 |
| K830038 | SIGMA 7000-6000 INFUSION PUMPS | Sigma | 1983-01-26 | 8 | 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