Cleared Traditional

K201302 - LiveOne (FDA 510(k) Clearance)

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

K201302 · Livemetric (Medical) S.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
719d
Days
Class 2
Risk

K201302 is an FDA 510(k) clearance for the LiveOne. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Livemetric (Medical) S.A. (Luxemburg, LU). The FDA issued a Cleared decision on May 4, 2022 after a review of 719 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Livemetric (Medical) S.A. devices

Submission Details

510(k) Number K201302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2020
Decision Date May 04, 2022
Days to Decision 719 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
594d slower than avg
Panel avg: 125d · This submission: 719d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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
NCT03919136 Unknown Observational

Wrist Worn Blood Pressure Measurement

Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement

40
Patients (est.)
3
Sites
Condition studied Blood Pressure; Heart Failure; Advanced Heart Failure; Heart Failure，Congestive
Eligibility All sexes · 18 Years+
Principal investigator Gabriel Sayer, MD
Sponsor LiveMetric S.A.
Started 2018-08-01 → Primary completion 2019-10-01
Primary outcome
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis
View full study on ClinicalTrials.gov

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 1209
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