Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sgm Biotech, 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) |
|---|---|---|---|---|---|
| K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK | Sgm Biotech, Inc. | 2010-05-14 | 155 | 2 |
| K091950 | SMART-WELL EZTEST INCUBATOR | Sgm Biotech, Inc. | 2010-01-15 | 198 | 0 |
| K963841 | EZTEST | Sgm Biotech, Inc. | 1997-02-25 | 153 | 1 |
| K930682 | EZTEST-STEAM | Sgm Biotech, Inc. | 1994-04-04 | 418 | 4 |
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