510(k) Report

FDA applicant

Myofunctional Research Corp. Pty., Ltd.

Helensvale, Queensland, AU3 decisions1993–20260 recalls

FDA records 3 decisions for Myofunctional Research Corp. Pty., Ltd. (Helensvale, Queensland, AU) from 1993 to 2026: 3 510(k) clearances. Most are in product codes KMY (Positioner, Tooth, Preformed) and LRK (Device, Anti-Snoring). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Myofunctional Research Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

FDA decisions per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Myofunctional Research Corp. 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?

  • KMYPositioner, Tooth, Preformed2decisions
  • LRKDevice, Anti-Snoring1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K924975The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 19931cites it
  • K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 20261cites it

What has FDA decided for it lately?

  • K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
  • K924975The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
  • K924974The TMJ ApplianceMyofunctional Research Corp. Pty., Ltd. · 1993

All 2 as Myofunctional Research Corp. Pty., Ltd. →The one decision as Myofunctional Research Co. →