Cleared Traditional

KardiaMobile 6L (K220350) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220350 · AliveCor, Inc. · Cardiovascular device
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May 2022
Decision
107d
Days
Class 2
Risk

K220350 is an FDA 510(k) clearance for the KardiaMobile 6L. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 25, 2022 after a review of 107 days - within the typical 510(k) review window.

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 AliveCor, Inc. devices

Submission Details

510(k) Number K220350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2022
Decision Date May 25, 2022
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Mdqr, LLC
Prabhu Raghavan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K220350.
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QT ECG
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Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
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KardiaMobile Card
K211668 · AliveCor, Inc. · Nov 2021
SimpleSENSE Platform
K212160 · Nanowear, Inc. · Sep 2021
KardiaMobile 6L
K210753 · AliveCor, Inc. · Jun 2021