510(k) Report

FDA applicant

Molnlycke Health Care, Inc.

Norcross, GA19 decisions1998–20140 recalls

FDA records 19 decisions for Molnlycke Health Care, Inc. (Norcross, GA) from 1998 to 2014: 19 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 27 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Molnlycke Health Care”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Molnlycke Health Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 12010: 22013: 22014: 2
2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Molnlycke Health Care, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug4decisions
  • KKXDrape, Surgical, Antimicrobial3decisions
  • FYAGown, Surgical3decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • MGPDressing, Wound And Burn, Occlusive2decisions
  • OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects1decision

Also: MSH (1), KMF (1), OMP (1), LZA (1).

Whose devices does it build on?

Its devices cite 27 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 5 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.

  • K100029Mepilex Border AG DressingMolnlycke Health Care · 20105cite it
  • K984371Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 19994cite it
  • K061554Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 20074cite it
  • K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film…Molnlycke Health Care · 20133cite it
  • K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 20142cite it
  • K983184MepilexMolnlycke Health Care, Inc. · 19981cites it

What has FDA decided for it lately?

  • K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014
  • K130040Mepitel AGMolnlycke Health Care · 2014
  • K123892Mepilex Transfer AGMolnlycke Health Care · 2013
  • K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film…Molnlycke Health Care · 2013
  • K102923Barrier N95 Particulate RespiratorMolnlycke Health Care · 2010
  • K100029Mepilex Border AG DressingMolnlycke Health Care · 2010
  • K061554Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 2007
  • K062138Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination GloveMolnlycke Health Care, Inc. · 2006

All 10 as Molnlycke Health Care, Inc. →All 9 as Molnlycke Health Care →

Other applicant names beginning “Molnlycke”

FDA records each applicant name separately; these may or may not be the same firm.

Molnlycke Health Care Us, LLC 27Molnlycke A/S Hospital Products 3Molnlycke/Scott Health Care 1Molnlycke Health Care USA 1Molnlycke Clinical Products AB 1