FDA applicant

Isothermal Systems, Inc.

Mchenry, IL2 decisions1977–19800 recalls

FDA records 2 decisions for Isothermal Systems, Inc. (Mchenry, IL) from 1977 to 1980: 2 510(k) clearances. Most are in product codes BXA (Analyzer, Gas, Water Vapor, Gaseous-Phase) and BZO (Set, Tubing And Support, Ventilator (W Harness)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Isothermal Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Isothermal Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?