Data / Medical devices / Australia / Micropace Pty. Ltd.
Micropace Pty. Ltd.: FDA-registered device maker in Homebush West New South Wales, Australia, 3 510(k) clearances
Micropace Pty. Ltd. is registered with the FDA (registration 3003617581) in Homebush West New South Wales, Australia. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003617581
- Address
- 41/159 Arthur Street, Homebush West New South Wales, Australia, 2140
- Owner or operator
- MICROPACE PTY. LTD. (9044248)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- July 11, 2001
- Registered through
- 2027
- Brand names listed
- EP Y Adaptor Cable, EPS320 CARDIAC STIMULATOR, MedConnect Adaptor Cable, ORLAB Cardiac Stimulator, OneLINK Splitter Cable, OneStim-DUO Cardiac Stimulator, SGU Replacement Spares for EPS320 Family, STIMCOR CARDIAC STIMULATOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | JOQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | DQK | Substantially Equivalent | Micropace Pty, Ltd. | accessdata.fda.gov |
| October 26, 2007 | K072200 | STIMLAB | JOQ | Substantially Equivalent | Micropace Pty, Ltd. | accessdata.fda.gov |
| January 24, 2002 | K011826 | EPS320 CARDIAC STIMULATOR | JOQ | Substantially Equivalent | Micropace Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- All makers of Cable, Electrode
- All makers of Computer, Diagnostic, Programmable
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.