510(k) Report

FDA applicant

Aga-Linde Health Care

Solon, OH1 decision2004–20040 recalls

FDA records 1 decision for Aga-Linde Health Care (Solon, OH) in 2004: 1 510(k) clearance. All are in product code ECX (Cylinder, Compressed Gas, And Valve). 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 Aga-Linde Health Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aga-Linde Health Care since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aga-Linde Health Care 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?

  • ECXCylinder, Compressed Gas, And Valve1decision

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.

  • K033897Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 20043cite it

What has FDA decided for it lately?

  • K033897Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004

The one decision as Aga-Linde Health Care →