3M Company: FDA filings under this applicant name

FDA lists 334 510(k) clearances under 3 spellings of the applicant name “3M Company” (first 1976, latest 2025), plus 1 PMA and 2 De Novo decisions, across 117 product codes in 16 review panels. Median 510(k) review time under this name: 68 days. Since 2017 the median was 90 days, against 130 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name 3M Company 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 107 more product codes.

Review panels

• General Hospital (97)
• Dental (70)
• General and Plastic Surgery (44)
• Cardiovascular (32)
• Orthopedic (26)
• Ear, Nose and Throat (16)
• Immunology (15)
• Radiology (9)
• Neurology (7)
• Anesthesiology (6)
• Microbiology (4)
• Physical Medicine (4)
• Clinical Chemistry (2)
• Obstetrics and Gynecology (1)
• Ophthalmic (1)
• Clinical Toxicology (1)

Most recent 3M Company 510(k) clearances

324 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-04-22.

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.

Device clinical trials

An industry sponsor named 3M Company is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03764059: Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations (Completed, started 2017-10-17)
• NCT01670760: Zero Heat Flux Thermometry System Comparison Trial (Completed, started 2013-04)
• NCT01417234: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds (Completed, started 2011-06)
• NCT00951080: SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds (Completed, started 2009-07)

SEC filings

3M CO (MMM): EDGAR filings, CIK 66740. An SEC registrant with the same name, matched by name only.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under 3M Company (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)

FDA spellings included

FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• 3M Company (332)
• 3M (4)
• 3M Company Corp (1)

Frequently asked questions

How many FDA 510(k) clearances are listed under 3M Company?

FDA lists 334 510(k) clearances under 3 spellings of the applicant name “3M Company” (first 1976, latest 2025), plus 1 PMA and 2 De Novo decisions, across 117 product codes in 16 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 Company?

The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Company is 68 days. Since 2017: 90 days, versus 130 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under 3M Company?

The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 32); JOJ (Indicator, Physical/Chemical Sterilization Process, 24); EBF (Material, Tooth Shade, Resin, 18).

Next steps

• See all 334 3M Company clearances with predicates and recalls
• Run predicate analysis for product code FRC, 3M Company'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.

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