FDA applicant
Spirotech, Inc.
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
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.
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.
See the 510(k) Report