Cleared Traditional

K181882 - eKuore One electronic interface for ste...

K181882 is an FDA 510(k) clearance for eKuore One electronic interface for ste..., manufactured by Chip Ideas Electronics S.L.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 257-day FDA review.

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

FDA 510(k) Submission Details - K181882

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.

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 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