Cleared Traditional

K151319 - Eko Electronic Stethoscope System (FDA 510(k) Clearance)

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

K151319 · Eko Devices, Inc. · Cardiovascular device
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Aug 2015
Decision
102d
Days
Class 2
Risk

K151319 is an FDA 510(k) clearance for the Eko Electronic Stethoscope System. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Eko Devices, Inc. (Berkeley, US). The FDA issued a Cleared decision on August 28, 2015 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Eko Devices, Inc. devices

Submission Details

510(k) Number K151319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date August 28, 2015
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 Peers - DQD Stethoscope, Electronic

All 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K151319.
Tyto Stethoscope (G3)
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eMurmur Heart AI
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K242971 · Heroic Faith International , Ltd. · Nov 2024