ZEUS System (Zio Watch)

K213409

iRhythm Technologies, Inc. · cleared 2022-07-19 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The ZEUS System (Zio Watch), the subject device of this 510(k) submission, is a software as a medical device (SaMD) system consisting of a collection of modules designed to process and analyze data from the Zio Watch into a curated report of preliminary findings intended for use by clinicians to aid in AF diagnosis.”
Algorithmartificial intelligence (AI) based analysis software, machine learning techniques
source quote (p.5)
“The subject ZEUS System utilizes an artificial intelligence (AI) based ECG Analysis Software (ECGDL) to generate the initial ECG-based cardiac information provided to the clinician in Transmission Reports. In addition, continuously recorded PPG-based data is processed by a separate artificial intelligence (AI) based analysis software, the AF Context Engine (ACE), that detects the presence of AF. Specifically, the subject ZEUS System (Zio Watch) utilizes machine learning techniques for both the ECGDL and AF Context Engine algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (2)

Bench

sample size not stated

standards: AAMI ANSI ISO 14971:2012(R)2010 (Corrected 4 October 2017), IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, AAMI ANSI IEC 60601-2-47:2012, AAMI ANSI EC57:2012, U.S. FDA October 2, 2014 Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, U.S. FDA May 5, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, U.S. FDA September 6, 2017 Design Considerations and Premarket Submission Recommendations for Interoperable, U.S. FDA July 2014 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Bench

sample size not stated

standards: AAMI ANSI ISO 14971:2012(R)2010 (Corrected 4 October 2017), IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, AAMI ANSI IEC 60601-2-47:2012, AAMI ANSI EC57:2012, U.S. FDA October 2, 2014 Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, U.S. FDA May 5, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, U.S. FDA September 6, 2017 Design Considerations and Premarket Submission Recommendations for Interoperable, U.S. FDA July 2014 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K222389 (decision 2023-02-15) from iRhythm Technologies, Inc. for a matching device line ("ZEUS System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K222389

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213409