Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
3M Company-3M Health Care · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103277 | 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M | 3M Company-3M Health Care | 2011-04-19 | 165 | 1 |
| K080620 | MODIFICATION TO 3M TEGADERM CHG DRESSING | 3M Company-3M Health Care | 2008-05-19 | 76 | 1 |
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