510(k) Report

FDA applicant

3M Company-3M Health Care

St. Paul, MN2 decisions2008–20112 recalls

FDA records 2 decisions for 3M Company-3M Health Care (St. Paul, MN) from 2008 to 2011: 2 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and FRO (Dressing, Wound, Drug). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2011

2008: 12011: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2024

2014: 12024: 1
2008high 1 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — 3M Company-3M Health Care by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRCIndicator, Biological Sterilization Process1decision
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1032773M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader3M Company-3M Health Care · 20115cite it
  • K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 20084cite it

What has FDA decided for it lately?

  • K1032773M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader3M Company-3M Health Care · 20111 recall
  • K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 20081 recall

All 2 as 3M Company-3M Health Care →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K1236793M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658RAug 14, 2024Class II
  • K1032773M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the…Jun 9, 2014Class II