Study Watch

K182456

Verily Life Sciences LLC · cleared 2019-01-17 · product code DXH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: predetermined acceptance criteria

standards: ISO 14971 (2012): Medical Devices - Application of Risk Managementto Medical Devices., IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-47:2012/ (R)2016 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems., IEC 62133 Battery Safety Testing, IEC 62304:2006 Medical device software -- Software life cycle processes, ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISTA 2A (2011): Partial Simulation Performance Tests (Packaging). Packaged-Products 150 lb (68 kg) Or Less.

Retrospective clinical

sample size not stated

endpoints: clinical quality requirements for an accurate ECG waveform display; qualitative clinical equivalence; inter-beat interval Bland-Altman analysis with Bias of 1.2ms and 95% limits-of-agreement <20ms

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

1
recalls in product code, 24mo
28
MAUDE reports in code, 12mo
+950%
vs code's own 3-yr baseline
4
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K213357 (decision 2022-07-19) from Verily Life Sciences LLC for a matching device line ("Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213357

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K192415 (decision 2020-01-17) from Verily Life Sciences LLC for a matching device line ("Study Watch with Irregular Pulse Monitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K192415

  • adverse_event_inflection

    MAUDE adverse-event reports for product code DXH: 28 in the 12 months ending 2026-06, vs a 2.7/12mo average over the prior 3 windows (+950%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=DXH

  • recall_reason_pattern

    Software/algorithm-related recall in product code DXH (GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China, initiated 2026-04-21): "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98917

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/K182456