510(k) Report

FDA applicant

Hougen Mfg., Inc.

Swartz Creek, MI2 decisions1998–19980 recalls

FDA records 2 decisions for Hougen Mfg., Inc. (Swartz Creek, MI) in 1998: 2 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and BYI (Percussor, Powered-Electric). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Hougen Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hougen Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hougen Mfg., 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?

  • BWFSpirometer, Therapeutic (Incentive)1decision
  • BYIPercussor, Powered-Electric1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K974848Mini-CiserHougen Mfg., Inc. · 19981cites it

What has FDA decided for it lately?

  • K974848Mini-CiserHougen Mfg., Inc. · 1998
  • K974849X-Air-CiserHougen Mfg., Inc. · 1998

All 2 as Hougen Mfg., Inc. →