3M Healthcare: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “3M Healthcare” (first 1991, latest 2020), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 118 days, against 123 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 182 |
| 2015 | 0 | — |
| 2016 | 1 | 252 |
| 2017 | 1 | 118 |
| 2018 | 2 | 74 |
| 2019 | 1 | 113 |
| 2020 | 1 | 122 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 3M Healthcare took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (8)
- Cardiovascular (6)
- General and Plastic Surgery (4)
- Dental (1)
- Neurology (1)
- Orthopedic (1)
Most recent 3M Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | QKM | 2020-03-13 | 122 |
| K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask | FXX | 2019-09-11 | 113 |
| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | FXX | 2018-07-31 | 119 |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | NJM | 2018-03-16 | 30 |
| K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | MSH | 2017-08-10 | 118 |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | KMF | 2016-08-23 | 252 |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | KKX | 2014-08-18 | 189 |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | KKX | 2014-07-25 | 175 |
| K974445 | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 | DRX | 1998-07-26 | 243 |
| K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | DRY | 1998-05-15 | 79 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Healthcare.
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?
FDA lists 21 510(k) clearances under the applicant name “3M Healthcare” (first 1991, latest 2020), across 13 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 Healthcare?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Healthcare is 118 days. Since 2017: 118 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 3M Healthcare?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 4); DRX (Electrode, Electrocardiograph, 2); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 2).
Next steps
- See all 21 3M Healthcare clearances with predicates and recalls
- Run predicate analysis for product code KKX, 3M Healthcare'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.