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FDA 510(k)

ZEUS Platform (FG0501US)

K-Number: K252859 · 2026-05-29

ApplicantiRhythm Technologies, Inc.
Decision Date2026-05-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZEUS Platform (FG0501US) 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 2026-05-29 under 510(k) number K252859. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS Platform (FG0501US)?

ZEUS Platform (FG0501US) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K252859.

When did ZEUS Platform (FG0501US) receive FDA 510(k) clearance?

ZEUS Platform (FG0501US) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252859.

Who is the listed applicant for ZEUS Platform (FG0501US)?

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 ZEUS Platform (FG0501US)?

The FDA product code for ZEUS Platform (FG0501US) is DQK.

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.

K243650Zio® monitor (DFG0001)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: DQK)

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.

K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.

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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