510(k) Report

FDA applicant

North American Grager

Telford, PA1 decision1995–19950 recalls

FDA records 1 decision for North American Grager (Telford, PA) in 1995: 1 510(k) clearance. All are in product code CAD (Vaporizer, Anesthesia, Non-Heated). 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 North American Grager’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North American Grager since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — North American Grager 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?

  • CADVaporizer, Anesthesia, Non-Heated1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K942055Drager-Vapor 19.1North American Grager · 19952cite it

What has FDA decided for it lately?

  • K942055Drager-Vapor 19.1North American Grager · 1995

The one decision as North American Grager →