510(k) Report

FDA applicant

Molnlycke Health Care Us, LLC

Norcross, GA27 decisions2006–20230 recalls

FDA records 27 decisions for Molnlycke Health Care Us, LLC (Norcross, GA) from 2006 to 2023: 27 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 38 predicates, 14 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

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

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

FDA decisions per year

1in 2023

2007: 42008: 12011: 22012: 12013: 12014: 12015: 42016: 62019: 12020: 32021: 12023: 1
2007high 6 (2016) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Molnlycke Health Care Us, LLC’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?

  • KGOSurgeon'S Gloves16decisions
  • OMPNegative Pressure Wound Therapy Powered Suction Pump7decisions
  • DWJSystem, Thermal Regulating2decisions
  • FRODressing, Wound, Drug1decision
  • OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 9 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 38 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 14 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.

  • K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 20155cite it
  • K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 20072cite it
  • K151872Avance Y-Connector SMolnlycke Health Care Us, LLC · 20152cite it
  • K111413Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 20122cite it
  • K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC · 20192cite it
  • K062847Biogel Eclipse Indicator UndergloveMolnlycke Health Care Us, LLC · 20061cites it

What has FDA decided for it lately?

  • K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC · 2023
  • K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC · 2021
  • K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel…Molnlycke Health Care Us, LLC · 2020
  • K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI…Molnlycke Health Care Us, LLC · 2020
  • K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel (R) PI UltraTouch S…Molnlycke Health Care Us, LLC · 2020
  • K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC · 2019
  • K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC · 2016
  • K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC · 2016

All 27 as Molnlycke Health Care Us, LLC →

Other applicant names beginning “Molnlycke”

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

Molnlycke Health Care, Inc. 19Molnlycke A/S Hospital Products 3Molnlycke/Scott Health Care 1Molnlycke Health Care USA 1Molnlycke Clinical Products AB 1