510(k) Report

FDA applicant

Micropace Pty, Ltd.

Canterbury, Nsw, AU3 decisions2002–20260 recalls

FDA records 3 decisions for Micropace Pty, Ltd. (Canterbury, Nsw, AU) from 2002 to 2026: 3 510(k) clearances. Most are in product codes JOQ (Generator, Pulse, Pacemaker, External…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 4 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2007

2007: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Micropace 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?

  • JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2decisions
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K011826EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 20024cite it
  • K072200StimlabMicropace Pty, Ltd. · 20071cites it

What has FDA decided for it lately?

  • K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026
  • K072200StimlabMicropace Pty, Ltd. · 2007
  • K011826EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002

All 3 as Micropace Pty, Ltd. →