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FDA 510(k)

Zio® monitor (DFG0001)

K-Number: K243650 · 2025-08-15

ApplicantiRhythm Technologies, Inc.
Decision Date2025-08-15
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio® monitor (DFG0001) is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K243650. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zio® monitor (DFG0001)?

Zio® monitor (DFG0001) is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K243650.

When did Zio® monitor (DFG0001) receive FDA 510(k) clearance?

Zio® monitor (DFG0001) received FDA 510(k) clearance on 2025-08-15, under 510(k) number K243650.

Who is the listed applicant for Zio® monitor (DFG0001)?

The FDA 510(k) record lists iRhythm Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zio® monitor (DFG0001)?

The FDA product code for Zio® monitor (DFG0001) is DSH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07205367Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA IICOMPLETED

Other records listing iRhythm Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252859ZEUS Platform (FG0501US)K240177Zio AT® device (A100A1001)K240029Zio AT® device (A100A1001)K222389ZEUS SystemK213409ZEUS System (Zio Watch)K202527Zio ECG Utilization Software (ZEUS) System

View all 11 devices →

Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.K232670HiCardi+ H100MEZOO Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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