Cleared Traditional

K203168 - LifeLens Wireless ECG Monitor (FDA 510(k) Clearance)

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

K203168 · LifeLens Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
270d
Days
Class 2
Risk

K203168 is an FDA 510(k) clearance for the LifeLens Wireless ECG Monitor. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by LifeLens Technologies, Inc. (Warminster, US). The FDA issued a Cleared decision on July 20, 2021 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 LifeLens Technologies, Inc. devices

Submission Details

510(k) Number K203168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2020
Decision Date July 20, 2021
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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

Mcra, LLC
Nicole Batista

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 - DSH Recorder, Magnetic Tape, Medical

All 193
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