510(k) Report

FDA applicant

3M Company, 3M Healthcare

St. Paul, MN1 decision2017–20170 recalls

FDA records 1 decision for 3M Company, 3M Healthcare (St. Paul, MN) in 2017: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided 3M Company, 3M Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — 3M Company, 3M Healthcare by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3M Company, 3M Healthcare’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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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing3M Company, 3M Healthcare · 2017

The one decision as 3M Company, 3M Healthcare →