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510(k) K252859

ZEUS Platform (FG0501US) by iRhythm Technologies, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
September 9, 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 iRhythm Technologies, Inc.

  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K240029 — Zio AT® device (A100A1001) (October 21, 2024)
  • K222389 — ZEUS System (February 15, 2023)
  • K213409 — ZEUS System (Zio Watch) (July 19, 2022)
  • K202359 — Zio Monitor (May 21, 2021)
  • K202527 — Zio ECG Utilization Software (ZEUS) System (May 21, 2021)
  • K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (August 23, 2019)
  • K181502 — Zio AT ECG Monitoring System, ZEUS System (August 29, 2018)
  • K163512 — Zio AT ECG Monitoring System (June 2, 2017)

Other clearances for product code DQK

  • K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO) (June 12, 2026)
  • K261329 — Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Cat (June 10, 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)