FDA applicant

Spirometrics, Inc.

Auburn, ME11 decisions1983–19920 recalls

FDA records 11 decisions for Spirometrics, Inc. (Auburn, ME) from 1983 to 1992: 11 510(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 Spirometrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spirometrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spirometrics, 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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Other applicant names beginning “Spirometrics”

FDA records each applicant name separately; these may or may not be the same firm.

Spirometrics Medical Equipment Co. 3

Spirometrics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spirometrics”