Cleared Traditional

eKuore One Wireless Electronic Interface for stethoscope (K201742) - FDA 510(k) Clearance

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

K201742 · Chip Ideas Electronics S.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
152d
Days
Class 2
Risk

K201742 is an FDA 510(k) clearance for the eKuore One Wireless Electronic Interface for stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Chip Ideas Electronics S.L. (Burjasot, ES). The FDA issued a Cleared decision on November 24, 2020 after a review of 152 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 K201742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2020
Decision Date November 24, 2020
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
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 K201742.
PrevisEA Device
K211068 · Entac Medical, Inc. · Aug 2021
doctorgram Stethoscope DES-I
K210736 · Gv Concepts · Jul 2021
MyHomeDoc
K202483 · Myhomedoc , Ltd. · Mar 2021
eKuore Pro Series
K203007 · Chip Ideas Electronics S.L. · Oct 2020
Stethee Pro 1, Stethee Pro Software System
K193631 · M3Dicine Pty , Ltd. · Oct 2020
Feelix Stethoscope
K200862 · Sonavi Labs, Inc. · Sep 2020