Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3M — 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) |
|---|---|---|---|---|---|
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V | 3M | 2023-03-23 | 182 | 0 |
| K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023-02-13 | 112 | 1 |
| K220560 | Dermatac Drape | 3M | 2022-07-14 | 136 | 0 |
| K200092 | 3MTM AttestTM Mini Auto-reader 490M | 3M | 2020-04-15 | 90 | 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