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510(k) K240177

Zio AT® device (A100A1001) by iRhythm Technologies, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by iRhythm Technologies, Inc.

  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K240029 — Zio AT® device (A100A1001) (October 21, 2024)
  • K222389 — ZEUS System (February 15, 2023)
  • K213409 — ZEUS System (Zio Watch) (July 19, 2022)
  • 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 DSI

  • K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) (January 23, 2026)
  • K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (July 29, 2025)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)