OneStim-DUO Cardiac Stimulator (MP5003-4CO)— 510(k) K253088
Substantially EquivalentMicropace Pty, Ltd.
FDA 510(k) clearance K253088 for OneStim-DUO Cardiac Stimulator (MP5003-4CO), Substantially Equivalent on 2026-06-12. Applicant: Micropace Pty, Ltd.. Device class: 2.
Summary
Micropace's OneStim-DUO Cardiac Stimulator (MP5003-4CO) is filed under DQK, programmable diagnostic computers. The name describes a cardiac stimulator, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Micropace filed from Homebush W., Australia. Review took 262 calendar days (September 23, 2025 to June 12, 2026).
Clearance details
- Applicant
- Micropace Pty, Ltd.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Homebush W., AU
Recent devices under product code DQK
view allMore clearances from Micropace Pty, Ltd.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.