510(k) Report

FDA applicant

Health Scan, Inc.

Mchenry, IL4 decisions1982–19960 recalls

FDA records 4 decisions for Health Scan, Inc. (Mchenry, IL) from 1982 to 1996: 4 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and BZH (Meter, Peak Flow, Spirometry). 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 Health Scan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Scan, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Health Scan, 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

Which product codes does it file in?

  • BWFSpirometer, Therapeutic (Incentive)2decisions
  • BZHMeter, Peak Flow, Spirometry1decision
  • BZGSpirometer, Diagnostic1decision

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.

  • K842634Pflex Respiratory Muscle ExerciserHealth Scan, Inc. · 19841cites it

What has FDA decided for it lately?

  • K952909AutozoneHealth Scan, Inc. · 1996
  • K842634Pflex Respiratory Muscle ExerciserHealth Scan, Inc. · 1984
  • K820528Pflex TMHealth Scan, Inc. · 1982
  • K820032Vit-O-MeterHealth Scan, Inc. · 1982

All 4 as Health Scan, Inc. →