Cleared Traditional

CORE 500 Digital Stethoscope (K230111) - FDA 510(k) Clearance

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

K230111 · Eko Devices, Inc. · Cardiovascular device
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May 2023
Decision
129d
Days
Class 2
Risk

K230111 is an FDA 510(k) clearance for the CORE 500 Digital Stethoscope. 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 May 26, 2023 after a review of 129 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 K230111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date May 26, 2023
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 K230111.
Stethophone
K231551 · Sparrow Acoustics, Inc. · Oct 2023
SKEEPER
K230613 · Smartsound Corporation · Aug 2023
AusculThing ACC
K230823 · Ausculthing OY · Jul 2023
PrevisEA Device
K230769 · Entac Medical, Inc. · May 2023
N9+
K223785 · Nonagon , Ltd. · Apr 2023
Stethophone v1
K222871 · Sparrow Acoustics, Inc. · Mar 2023