510(k) Report

FDA applicant

Engstrom Medical

Sturgis, MI2 decisions1995–19950 recalls

FDA records 2 decisions for Engstrom Medical (Sturgis, MI) in 1995: 2 510(k) clearances. Most are in product codes BYD (Condenser, Heat And Moisture (Artificial Nose)) and BZA (Connector, Airway (Extension)). 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 Engstrom Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Engstrom Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Engstrom Medical 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?

  • BYDCondenser, Heat And Moisture (Artificial Nose)1decision
  • BZAConnector, Airway (Extension)1decision

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.

  • K954194Disposable Hme/FilterEngstrom Medical · 19951cites it

What has FDA decided for it lately?

  • K954197Disposable Flex TubeEngstrom Medical · 1995
  • K954194Disposable Hme/FilterEngstrom Medical · 1995

All 2 as Engstrom Medical →