3M Health Care, Ltd.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “3M Health Care, Ltd.” (first 1990, latest 1996), across 27 product codes in 6 review panels. Median 510(k) review time under this name: 222 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 16 | 16 |
| KMF | Bandage, Liquid | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FRW | Scale, Patient | 2 | 2 |
| IWZ | Film, Radiographic | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| BRX | Stool, Anesthesia | 1 | 1 |
| DQD | Stethoscope, Electronic | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
Plus 17 more product codes.
Review panels
- General Hospital (24)
- Cardiovascular (10)
- General and Plastic Surgery (8)
- Orthopedic (4)
- Radiology (2)
- Anesthesiology (1)
Most recent 3M Health Care, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | DWB | 1996-04-19 | 245 |
| K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X | FRC | 1995-03-31 | 829 |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | KWY | 1995-03-06 | 341 |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | FLF | 1994-12-02 | 238 |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | FYA | 1994-02-10 | 365 |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | KIJ | 1994-01-07 | 241 |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | KGX | 1993-12-27 | 222 |
| K932446 | INJECTION SITE | FPA | 1993-11-29 | 193 |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | DRY | 1993-11-10 | 203 |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | FRN | 1993-10-25 | 126 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Health Care, Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under 3M Health Care, Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under 3M Health Care, Ltd.?
FDA lists 49 510(k) clearances under the applicant name “3M Health Care, Ltd.” (first 1990, latest 1996), across 27 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 3M Health Care, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Health Care, Ltd. is 222 days.
Which FDA product codes appear under 3M Health Care, Ltd.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 16); KMF (Bandage, Liquid, 3); DRX (Electrode, Electrocardiograph, 2).
Next steps
- See all 49 3M Health Care, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRN, 3M Health Care, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.