510(k) Report

FDA applicant

Stimlabs, LLC

Roswell, GA3 decisions2024–20250 recalls

FDA records 3 decisions for Stimlabs, LLC (Roswell, GA) from 2024 to 2025: 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 83 days from receipt to decision, against 83 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 Stimlabs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 22025: 1
2024high 2 (2024) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Stimlabs, LLC by year, 2024–2026Sources: 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 83 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 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:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K231325Corplex P / Theracor P / Allacor PStimlabs, LLC · 20243cite it

What has FDA decided for it lately?

  • K253339TheracorStimlabs, LLC · 2025
  • K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC · 2024
  • K231325Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024

All 3 as Stimlabs, LLC →