510(k) Report

FDA applicant

Info-Chem

Mchenry, IL5 decisions1977–19810 recalls

FDA records 5 decisions for Info-Chem (Mchenry, IL) from 1977 to 1981: 5 510(k) clearances. Most are in product codes FQZ (Thermometer, Clinical Color Change) and FRC (Indicator, Biological Sterilization Process). 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 Info-Chem’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Info-Chem since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Info-Chem 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?

  • FQZThermometer, Clinical Color Change3decisions
  • FRCIndicator, Biological Sterilization Process1decision
  • MMKContainer, Sharps1decision

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.

  • K771080Steam Sterilization IndicatorInfo-Chem · 19771cites it

What has FDA decided for it lately?

  • K810134Keep-Account Sharps Disposal SystemInfo-Chem · 1981
  • K791574Modified Tempa-Dot ThermometerInfo-Chem · 1979
  • K772233Thermometer Recal AdapterInfo-Chem · 1977
  • K771080Steam Sterilization IndicatorInfo-Chem · 1977
  • K771037Thermometer, Single Use, Strip, TempadotInfo-Chem · 1977

All 5 as Info-Chem →