510(k) Report

FDA applicant

Hospitax

Mchenry, IL1 decision1980–19801 recall

FDA records 1 decision for Hospitax (Mchenry, IL) in 1980: 1 510(k) clearance. All are in product code LCQ (Fluorescent Immunoassay Gentamicin). 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, clinical toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Hospitax since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hospitax 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?

  • LCQFluorescent Immunoassay Gentamicin1decision

What has FDA decided for it lately?

  • K801867Disposable Medication NebulizerHospitax · 19801 recall

The one decision as Hospitax →

What has been recalled?

1 recall linked to its devices; the latest:

  • K801867Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray…Nov 11, 2015Class II