Cleared Traditional

eKuore One electronic interface for stethoscope (K181882) - FDA 510(k) Clearance

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

K181882 · Chip Ideas Electronics S.L. · Cardiovascular device
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Mar 2019
Decision
257d
Days
Class 2
Risk

K181882 is an FDA 510(k) clearance for the eKuore One electronic interface for stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Chip Ideas Electronics S.L. (Valencia, ES). The FDA issued a Cleared decision on March 27, 2019 after a review of 257 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 Chip Ideas Electronics S.L. devices

Submission Details

510(k) Number K181882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2018
Decision Date March 27, 2019
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
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 K181882.
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
Tyto Stethoscope (OTC)
K181612 · Tyto Care , Ltd. · Dec 2018
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
K182196 · Imediplus, Inc. · Sep 2018
Electronic Stethoscope DS3011A
K173663 · Imediplus, Inc. · Aug 2018