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510(k) K213409

ZEUS System (Zio Watch) by iRhythm Technologies, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2022
Date Received
October 19, 2021
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)
  • K202527 — Zio ECG Utilization Software (ZEUS) System (May 21, 2021)
  • K202359 — Zio Monitor (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)
  • K143513 — ZIO SR ECG Monitoring Service (June 19, 2015)

Other clearances for product code DQK

  • 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)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)