510(k) Report

FDA applicant

Aerosport, Inc.

Ann Arbor, MI1 decision1995–19950 recalls

FDA records 1 decision for Aerosport, Inc. (Ann Arbor, MI) in 1995: 1 510(k) clearance. All are in product code BZC (Calculator, Pulmonary Function Data). 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 Aerosport, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aerosport, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aerosport, 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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Which product codes does it file in?

  • BZCCalculator, Pulmonary Function Data1decision

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.

  • K945213TEEN 100Aerosport, Inc. · 19951cites it

What has FDA decided for it lately?

  • K945213TEEN 100Aerosport, Inc. · 1995

The one decision as Aerosport, Inc. →