FDA applicant

Gkc Manufacturing Pty, Ltd.

Melbourne, AU3 decisions2014–20220 recalls

FDA records 3 decisions for Gkc Manufacturing Pty, Ltd. (Melbourne, AU) from 2014 to 2022: 3 510(k) clearances. All are in product code GYD (Transducer, Tremor). Its devices cite 6 predicates, 2 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, neurology panel, where it files most

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

FDA decisions per year

1in 2022

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Gkc Manufacturing Pty, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gkc Manufacturing Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Gkc Manufacturing Pty, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?