510(k) Report

FDA applicant

Kedl Internation Limited

Fort Myers, FL1 decision2008–20080 recalls

FDA records 1 decision for Kedl Internation Limited (Fort Myers, FL) in 2008: 1 510(k) clearance. All are in product code CAW (Generator, Oxygen, Portable). 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 Kedl Internation Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Kedl Internation Limited by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CAWGenerator, Oxygen, Portable1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K081267Hygeia-5 Oxygen ConcentratorKedl Internation Limited · 2008

The one decision as Kedl Internation Limited →