Cleared Traditional

K170874 - Eko Model E5 System (EME5), Eko DUO

K170874 is an FDA 510(k) clearance for Eko Model E5 System (EME5), 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 56-day FDA review.

K170874 · Eko Devices, Inc. · Cardiovascular device
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May 2017
Decision
56d
Days
Class 2
Risk

K170874 is an FDA 510(k) clearance for the Eko Model E5 System (EME5), Eko DUO. 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 May 19, 2017 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eko Devices, Inc. devices

FDA 510(k) Submission Details - K170874

510(k) Number K170874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2017
Decision Date May 19, 2017
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
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 Consultant

Righter Consulting Group, LLC
Michael Righter

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 - DQD Stethoscope, Electronic

All 122
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K170874.
CliniCloud Stethoscope
K173448 · Stethocloud Pty.Ltd (Clinicloud) · Jan 2018
Stethee Pro
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CADence System
K170928 · Aum Cardiovascular, Inc. · Aug 2017
Adscope 658 Electronic Stethoscope
K162589 · American Diagnostic Corp. · Mar 2017
Tyto Stethoscope
K160401 · Tyto Care , Ltd. · Oct 2016
Electronic Stethoscope DS301
K160023 · Imediplus, Inc. · Sep 2016