Study Watch with Irregular Pulse Monitor

K192415

Verily Life Sciences LLC · cleared 2020-01-17 · product code DXH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“The Study Watch with Irregular Pulse Monitor is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended to notify the user in the event of irregular pulse, such as atrial fibrillation (AF), and recommend acquisition of an ECG.”
AlgorithmPPG-based Irregular Pulse Monitor algorithm
source quote (p.4)
“Specifically, the primary clinical study collected Study Watch PPG waveform (Test) data in clinic from patients with a history of AF and applied the PPG-based Irregular Pulse Monitor algorithm, using contemporaneous Holter ECG (Reference) data as ground truth.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: per-interval sensitivity; specificity for continuous monitoring

Reported performance (2 observations)

sensitivity0.85CI 0.79-0.90
source quote (p.4)
“The presented data include the primary endpoints [per-interval sensitivity 0.85 (0.79-0.90) and specificity 0.96 (0.93-0.99)]”
specificity0.96CI 0.93-0.99
source quote (p.4)
“The presented data include the primary endpoints [per-interval sensitivity 0.85 (0.79-0.90) and specificity 0.96 (0.93-0.99)]”

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
3
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

  • 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/K192415