Cleared Traditional

K213794 - Eko Murmur Analysis Software (EMAS)

K213794 is an FDA 510(k) clearance for Eko Murmur Analysis Software (EMAS), manufactured by Eko Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K213794 · Eko Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
205d
Days
Class 2
Risk

K213794 is an FDA 510(k) clearance for the Eko Murmur Analysis Software (EMAS). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Eko Devices, Inc. (Oakland, US). The FDA issued a Cleared decision on June 29, 2022 after a review of 205 days - an extended review cycle.

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

FDA 510(k) Submission Details - K213794

510(k) Number K213794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2021
Decision Date June 29, 2022
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K213794.
Medaica M1 Telehealth Stethoscope
K223166 · Medaica, Inc. · Jan 2023
ibiomedi Electronic Stethoscope ES-2020
K220466 · Sound Land Corp. · Nov 2022
eClinic Stethopod
K220099 · Homediagnostic, LLC · Oct 2022
eMurmur Heart AI
K220766 · Csd Labs GmbH · May 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
K211779 · Chip Ideas Electronics S.L. · May 2022
Smart Wireless Stethoscope
K220470 · Shanghai Hulu Devices Co., Ltd. · May 2022