510(k) Report

FDA applicant

Kerecis Limited

Isafjordur, IS11 decisions2013–20250 recalls

FDA records 11 decisions for Kerecis Limited (Isafjordur, IS) from 2013 to 2025: 11 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and OXH (Mesh, Surgical, Collagen, Plastic And…). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kerecis”.

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 Kerecis Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2013: 12016: 12019: 12020: 12021: 12022: 22024: 12025: 3
2013high 3 (2025) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Kerecis Limited by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)5decisions
  • OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2decisions
  • NPLBarrier, Animal Source, Intraoral2decisions
  • OXEMesh, Surgical, Collagen, Staple Line Reinforcement1decision
  • OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 9 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.

  • K202430Kerecis ReconstructKerecis Limited · 20213cite it
  • K190528MariGen Wound ExtraKerecis Limited · 20193cite it
  • K132343Marigen Wound DressingKerecis Limited · 20132cite it
  • K213231Kerecis SiliconeKerecis Limited · 20221cites it
  • K241080Kerecis Parvus (50207)Kerecis Limited · 20241cites it

What has FDA decided for it lately?

  • K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025
  • K251844Kerecis SurgiBind (50241)Kerecis Limited · 2025
  • K243843Tendon Protect (50242)Kerecis Limited · 2025
  • K241080Kerecis Parvus (50207)Kerecis Limited · 2024
  • K213904Kerecis OralKerecis · 2022
  • K213231Kerecis SiliconeKerecis Limited · 2022
  • K202430Kerecis ReconstructKerecis Limited · 2021
  • K192612Kerecis Gingiva GraftKerecis Limited · 2020

All 10 as Kerecis Limited →The one decision as Kerecis →