Cleared Traditional

Eko CORE (K200776) - FDA 510(k) Clearance

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

K200776 · Eko Devices, Inc. · Cardiovascular device
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Apr 2020
Decision
12d
Days
Class 2
Risk

K200776 is an FDA 510(k) clearance for the Eko CORE. 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 April 6, 2020 after a review of 12 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

Submission Details

510(k) Number K200776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2020
Decision Date April 06, 2020
Days to Decision 12 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
113d faster than avg
Panel avg: 125d · This submission: 12d
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 53
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K200776.
Stethee Pro 1, Stethee Pro Software System
K193631 · M3Dicine Pty , Ltd. · Oct 2020
Feelix Stethoscope
K200862 · Sonavi Labs, Inc. · Sep 2020
HD Steth
K201299 · Hd Medical, Inc. · Jul 2020
Electronic Stethoscope
K191667 · Hefei Mintti Medical Technology Co., Ltd. China · Dec 2019
Vivio System
K183710 · Avicena, LLC · Oct 2019
eMurmur ID
K181988 · Csd Labs GmbH · Apr 2019