Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sigma Medical Supplies 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) |
|---|---|---|---|---|---|
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018-06-05 | 83 | 0 |
| K133838 | STERILIZATION POUCH/ROLL MADE WITH TYVEK | Sigma Medical Supplies Corp. | 2015-03-11 | 448 | 0 |
| K102158 | SIGMA STERILIZATION POUCH & ROLL | Sigma Medical Supplies Corp. | 2011-08-02 | 368 | 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