510(k) Report

FDA applicant

Cryptych Pty, Ltd.

North Sydney, AU2 decisions2016–20200 recalls

FDA records 2 decisions for Cryptych Pty, Ltd. (North Sydney, AU) from 2016 to 2020: 2 510(k) clearances. Most are in product codes GWE (Stimulator, Photic, Evoked Response) and OLO (Orthopedic Stereotaxic Instrument). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2020

2016: 12020: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Cryptych Pty, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWEStimulator, Photic, Evoked Response1decision
  • OLOOrthopedic Stereotaxic Instrument1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K200705Nurochek SystemCryptych Pty, Ltd. · 2020
  • K160385Precision ScrewCryptych Pty, Ltd. · 2016

All 2 as Cryptych Pty, Ltd. →