510(k) Report

FDA applicant

Bio-Nustics, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Bio-Nustics, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code JKS (Spectral Absorb. Curve, Oxyhemoglobin…). 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, clinical toxicology panel, where it files most

How often FDA has decided Bio-Nustics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Nustics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Nustics, 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?

  • JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1decision

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.

  • K832066Control 282Bio-Nustics, Inc. · 19831cites it

What has FDA decided for it lately?

  • K832066Control 282Bio-Nustics, Inc. · 1983

The one decision as Bio-Nustics, Inc. →