510(k) Report

FDA applicant

Spirotech, Inc.

Mchenry, IL3 decisions1983–19840 recalls

FDA records 3 decisions for Spirotech, Inc. (Mchenry, IL) from 1983 to 1984: 3 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BTY (Calculator, Predicted Values, Pulmonary Function). 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 Spirotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spirotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spirotech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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