Home / 510(k) Clearances / K253088

510(k) K253088

OneStim-DUO Cardiac Stimulator (MP5003-4CO) by Micropace Pty, Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2026
Date Received
September 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Micropace Pty, Ltd.

  • K072200 — STIMLAB (October 26, 2007)
  • K011826 — EPS320 CARDIAC STIMULATOR (January 24, 2002)

Other clearances for product code DQK

  • K261329 — Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Cat (June 10, 2026)
  • K252859 — ZEUS Platform (FG0501US) (May 29, 2026)
  • K260212 — EnSite™ X EP System (April 20, 2026)
  • K253861 — ACORYS MAPPING SYSTEM (April 13, 2026)
  • K253473 — Synchrony (April 1, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)