510(k) Report

FDA applicant

Medskin Solutions Dr. Suwelack AG

Billerbeck, DE3 decisions2021–20260 recalls

FDA records 3 decisions for Medskin Solutions Dr. Suwelack AG (Billerbeck, DE) from 2021 to 2026: 3 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Medskin Solutions Dr. Suwelack AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Medskin Solutions Dr. Suwelack AG by year, 2021–2026Sources: 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)3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 210 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 174 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201577MatriDermMedskin Solutions Dr. Suwelack AG · 20212cite it

What has FDA decided for it lately?

  • K261224MatriDermMedskin Solutions Dr. Suwelack AG · 2026
  • K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG · 2025
  • K201577MatriDermMedskin Solutions Dr. Suwelack AG · 2021

All 3 as Medskin Solutions Dr. Suwelack AG →