510(k) Report

FDA applicant

Xenex Disinfection Services, Inc.

San Antonio, TX1 decision2023–20230 recalls

FDA records 1 decision for Xenex Disinfection Services, Inc. (San Antonio, TX) in 2023: 1 De Novo grant. All are in product code QXJ (Whole Room Microbial Reduction Device). No 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 Xenex Disinfection Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Xenex Disinfection Services, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QXJWhole Room Microbial Reduction Device1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • DEN230007LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc. · 20231cites it

What has FDA decided for it lately?

  • DEN230007LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc. · 2023

The one decision as Xenex Disinfection Services, Inc. →