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

- Pathway: 510(k) (Traditional)
- Applicant: Micropace Pty, Ltd.
- Decided: Jun 12, 2026 after 262 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862740 (1986). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183266: EP-TRACER System, Schwarzer Cardiotek GmbH (2019). Our reading of the summary gave K083266, FDA’s number for Gore Bio-a Fistula Plug (W. L. Gore & Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EP-Tracer System”.
- K011826: EPS320 Cardiac Stimulator, Micropace Pty, Ltd. (2002) Summary page 5.

## Indications for use
The OneStim is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record cardiac electrical signals combined with a programmable diagnostic cardiac stimulator intended to be used for testing of the heart during cardiac electrophysiological studies and related procedures in hospital facilities. The OneStim indicated for adult and pediatric population in the management of cardiac arrhythmias and conduction disorders.

Source page: https://510kreport.com/device/K253088
Methodology: https://510kreport.com/methodology