Cleared Traditional

ibiomedi Electronic Stethoscope ES-2020 (K220466) - FDA 510(k) Clearance

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

K220466 · Sound Land Corp. · Cardiovascular device
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Nov 2022
Decision
259d
Days
Class 2
Risk

K220466 is an FDA 510(k) clearance for the ibiomedi Electronic Stethoscope ES-2020. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Sound Land Corp. (Taoyuan, TW). The FDA issued a Cleared decision on November 3, 2022 after a review of 259 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 Sound Land Corp. devices

Submission Details

510(k) Number K220466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date November 03, 2022
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K220466.
AccurSound Electronic Stethoscope AS-101
K221805 · Heroic Faith International , Ltd. · Mar 2023
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Medaica M1 Telehealth Stethoscope
K223166 · Medaica, Inc. · Jan 2023
eClinic Stethopod
K220099 · Homediagnostic, LLC · Oct 2022
Eko Murmur Analysis Software (EMAS)
K213794 · Eko Devices, Inc. · Jun 2022
eMurmur Heart AI
K220766 · Csd Labs GmbH · May 2022