510(k) Report

FDA applicant

Best Sanitizers, Inc.

Euless, TX2 decisions2005–20101 recall

FDA records 2 decisions for Best Sanitizers, Inc. (Euless, TX) from 2005 to 2010: 2 510(k) clearances. All are in product code MED (Sterilant, Medical Devices). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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 hospital panel, where it files most

How often FDA has decided Best Sanitizers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Best Sanitizers, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MEDSterilant, Medical Devices2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K041984Acecide High-Level Disinfectant and SterilantBest Sanitizers, Inc. · 20052cite it

What has FDA decided for it lately?

  • K091210Acecide-C High Level Disinfectant and SterilantBest Sanitizers, Inc. · 20101 recall
  • K041984Acecide High-Level Disinfectant and SterilantBest Sanitizers, Inc. · 2005

All 2 as Best Sanitizers, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091210Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in…Aug 2, 2016Class II