510(k) Report

FDA applicant

Seriously Clean, Ltd.

Nixa, MO2 decisions2012–20250 recalls

FDA records 2 decisions for Seriously Clean, Ltd. (Nixa, MO) from 2012 to 2025: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 4 predicates, 0 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 Seriously Clean, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12025: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Seriously Clean, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 20123cite it

What has FDA decided for it lately?

  • K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd. · 2025
  • K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012

All 2 as Seriously Clean, Ltd. →