Cleared Traditional

K213357 - Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K213357 · Verily Life Sciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
280d
Days
Class 2
Risk

K213357 is an FDA 510(k) clearance for the Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular P.... Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Verily Life Sciences, LLC (South San Francisco, US). The FDA issued a Cleared decision on July 19, 2022 after a review of 280 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Verily Life Sciences, LLC devices

Submission Details

510(k) Number K213357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2021
Decision Date July 19, 2022
Days to Decision 280 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 125d · This submission: 280d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04546763 Completed Observational Industry-sponsored

Study Watch AF Detection At Home

117
Patients (actual)
5
Sites
Condition studied Atrial Fibrillation
Eligibility All sexes · 22 Years+
Principal investigator Hamid Ghanbari
Sponsor Verily Life Sciences LLC (industry)
Started 2020-09-03 → Primary completion 2021-05-14
Primary outcome
Accuracy of AF detection - Sensitivity
Secondary outcome
A sensitivity analysis estimating the range of sensitivities
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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All 296
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