FDA applicant
3M Company
FDA records 337 decisions for 3M Company (St. Paul, MN) from 1976 to 2025: 334 510(k) clearances, 2 De Novo grants and 1 original PMA approval. Most are in product codes FRC (Indicator, Biological Sterilization Process) and JOJ (Indicator, Physical/Chemical Sterilization…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 137 predicates, 70 of them its own earlier devices. 91 recalls are linked to its devices.
FDA’s records also spell it “3M”, “3M Company Corp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided 3M Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like 3M Company’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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