3M Healthcare Business Group: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “3M Healthcare Business Group” (first 2021, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 217 days. Since 2017 the median was 217 days, against 233 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Solventum (formerly 3M Health Care), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 140 |
| 2022 | 2 | 258 |
| 2023 | 1 | 295 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 3M Healthcare Business Group took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 233 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 4 | 4 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
Review panels
Most recent 3M Healthcare Business Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | OMP | 2023-03-23 | 295 |
| K220660 | Prevena Restor Adapti-Form Dressing | OMP | 2022-07-01 | 116 |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | FRO | 2022-02-24 | 401 |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) | OMP | 2021-12-20 | 217 |
| K212320 | Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac | OMP | 2021-09-28 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named 3M Healthcare Business Group.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under 3M Healthcare Business Group?
FDA lists 5 510(k) clearances under the applicant name “3M Healthcare Business Group” (first 2021, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 3M Healthcare Business Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Healthcare Business Group is 217 days. Since 2017: 217 days, versus 233 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 3M Healthcare Business Group?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 4); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 5 3M Healthcare Business Group clearances with predicates and recalls
- Run predicate analysis for product code OMP, 3M Healthcare Business Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.