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FDA 510(k)

OneStim-DUO Cardiac Stimulator (MP5003-4CO)

K-Number: K253088 · 2026-06-12

ApplicantMicropace Pty, Ltd.
Decision Date2026-06-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OneStim-DUO Cardiac Stimulator (MP5003-4CO) is the device name listed in this FDA 510(k) record. The listed applicant is Micropace Pty, Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253088. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

OneStim-DUO Cardiac Stimulator (MP5003-4CO) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Micropace Pty, Ltd.. The 510(k) number is K253088.

When did OneStim-DUO Cardiac Stimulator (MP5003-4CO) receive FDA 510(k) clearance?

OneStim-DUO Cardiac Stimulator (MP5003-4CO) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253088.

Who is the listed applicant for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

The FDA 510(k) record lists Micropace Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

The FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO) is DQK.

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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