510(k) Report

FDA applicant

Stantex Pty, Ltd.

Sydney, New South Wales, AU1 decision1992–19920 recalls

FDA records 1 decision for Stantex Pty, Ltd. (Sydney, New South Wales, AU) in 1992: 1 510(k) clearance. All are in product code MNK (Endoscopic Bite Block). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Stantex Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stantex Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stantex Pty, Ltd. 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?

  • MNKEndoscopic Bite Block1decision

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.

  • K914978OxyguardStantex Pty, Ltd. · 19922cite it

What has FDA decided for it lately?

  • K914978OxyguardStantex Pty, Ltd. · 1992

The one decision as Stantex Pty, Ltd. →