Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
3M Healthcare Business Group · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
401 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cl | 3M Healthcare Business Group | 2023-03-23 | 295 | 0 |
| K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | 2022-07-01 | 116 | 0 |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Ma | 3M Healthcare Business Group | 2022-02-24 | 401 | 0 |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dres | 3M Healthcare Business Group | 2021-12-20 | 217 | 0 |
| K212320 | Dermatacâ„¢ Drape and V.A.C. Granufoam Dressings Featuring Sen | 3M Healthcare Business Group | 2021-09-28 | 64 | 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