Solventum (formerly 3M Health Care): FDA 510(k) clearances across all its applicant names

FDA lists 589 510(k) clearances, 1 PMA and 3 De Novo decisions across the 26 applicant names Caduvo groups under Solventum (formerly 3M Health Care), first 1976, latest 2026. Median 510(k) review time across these names: 79 days. Since 2017 the median was 90 days, against 130 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 26 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.

Top product codes

Plus 141 more product codes.

Review panels

• General Hospital (145)
• Dental (140)
• General and Plastic Surgery (121)
• Cardiovascular (56)
• Orthopedic (32)
• Physical Medicine (21)
• Ear, Nose and Throat (18)
• Radiology (18)
• Immunology (15)
• Anesthesiology (8)
• Neurology (8)
• Microbiology (4)
• Clinical Chemistry (2)
• Obstetrics and Gynecology (1)
• Ophthalmic (1)
• Clinical Toxicology (1)

Most recent Solventum (formerly 3M Health Care) 510(k) clearances

579 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

57 product recalls in 34 recall events under these names; 6 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

3M's health care business was spun off as Solventum on April 1, 2024; 3M names are 3M's health-care filings before the spin. Includes KCI (acquired by 3M 2019). The plain 3M / 3M COMPANY names may include products 3M kept (e.g. some respirators) and cannot be split out. Left out: 3M Health Care Sarns (cardiovascular, sold to Terumo 1999), imaging and diagnostic-systems names (divested).

Sources

• https://en.wikipedia.org/wiki/Solventum
• https://en.wikipedia.org/wiki/Kinetic_Concepts

Frequently asked questions

How many FDA 510(k) clearances are listed across Solventum (formerly 3M Health Care)'s applicant names?

FDA lists 589 510(k) clearances, 1 PMA and 3 De Novo decisions across the 26 applicant names Caduvo groups under Solventum (formerly 3M Health Care), first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Solventum (formerly 3M Health Care) file under?

The names with the most 510(k) clearances in this group are 3M Company (330); 3M Health Care, Ltd. (49); Kinetic Concepts, Inc. (48); Kci USA, Inc. (27); 3M Espe AG Dental Products (24). The full list of 26 names is on this page.

How long does FDA take to clear Solventum (formerly 3M Health Care) 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 79 days. Since 2017 the median was 90 days, against 130 days for all cleared 510(k)s in the same product codes.

Does the Solventum (formerly 3M Health Care) count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 589 Solventum (formerly 3M Health Care) clearances with predicates and recalls
• Run predicate analysis for product code OMP, Solventum (formerly 3M Health Care)'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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