510(k) Report

FDA applicant

Trawax Pty Limited

Laguna Niguel, CA1 decision2008–20080 recalls

FDA records 1 decision for Trawax Pty Limited (Laguna Niguel, CA) in 2008: 1 510(k) clearance. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 3 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 Trawax Pty 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 — Trawax Pty 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?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K080527Twinguard with Capnograph AccessoryTrawax Pty Limited · 20081cites it

What has FDA decided for it lately?

  • K080527Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008

The one decision as Trawax Pty Limited →