510(k) Report

FDA applicant

Healthscan Products, Inc.

Cedar Grove, NJ5 decisions1993–19960 recalls

FDA records 5 decisions for Healthscan Products, Inc. (Cedar Grove, NJ) from 1993 to 1996: 5 510(k) clearances. Most are in product codes BZH (Meter, Peak Flow, Spirometry) and CAF (Nebulizer (Direct Patient Interface)). 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 Healthscan Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthscan Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • BZHMeter, Peak Flow, Spirometry3decisions
  • CAFNebulizer (Direct Patient Interface)1decision
  • BWFSpirometer, Therapeutic (Incentive)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K962822OptichamberHealthscan Products, Inc. · 19963cite it

What has FDA decided for it lately?

  • K962924Personal Best II with Zone Management SystemHealthscan Products, Inc. · 1996
  • K962929Personal Best IIHealthscan Products, Inc. · 1996
  • K962822OptichamberHealthscan Products, Inc. · 1996
  • K961077Pep (Positive Expiratory Pressure) Therapy DeviceHealthscan Products, Inc. · 1996
  • K933889Personal Best Low RangeHealthscan Products, Inc. · 1993

All 5 as Healthscan Products, Inc. →