Cleared Traditional

K253088 - OneStim-DUO Cardiac Stimulator (MP5003-4CO)

K253088 is an FDA 510(k) clearance for OneStim-DUO Cardiac Stimulator (MP5003-4CO), manufactured by Micropace Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K253088 · Micropace Pty, Ltd. · Cardiovascular device
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Jun 2026
Decision
262d
Days
Class 2
Risk

K253088 is an FDA 510(k) clearance for the OneStim-DUO Cardiac Stimulator (MP5003-4CO). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Micropace Pty, Ltd. (Homebush W., AU). The FDA issued a Cleared decision on June 12, 2026 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Micropace Pty, Ltd. devices

FDA 510(k) Submission Details - K253088

510(k) Number K253088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date June 12, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Acorn N Oakes, LLC
Amy Oakes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 395
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K253088.
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K252859 · iRhythm Technologies, Inc. · May 2026
EnSite™ X EP System
K260212 · Abbott Medical · Apr 2026

FDA 510(k) Resources - Cardiovascular

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.