510(k) Report

FDA applicant

Monlycke Health Care

Norcross, GA1 decision2007–20070 recalls

FDA records 1 decision for Monlycke Health Care (Norcross, GA) in 2007: 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 Monlycke Health Care’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Monlycke Health Care by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K071354Mepilex AG DressingMonlycke Health Care · 20071cites it

What has FDA decided for it lately?

  • K071354Mepilex AG DressingMonlycke Health Care · 2007

The one decision as Monlycke Health Care →