Cleared Special

eMurmur Heart AI (K220766) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220766 · Csd Labs GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
76d
Days
Class 2
Risk

K220766 is an FDA 510(k) clearance for the eMurmur Heart AI. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Csd Labs GmbH (Graz, AT). The FDA issued a Cleared decision on May 31, 2022 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Csd Labs GmbH devices

Submission Details

510(k) Number K220766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2022
Decision Date May 31, 2022
Days to Decision 76 days
Submission Type Special
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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

RQM+
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQD Stethoscope, Electronic

All 53
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K220766.
ibiomedi Electronic Stethoscope ES-2020
K220466 · Sound Land Corp. · Nov 2022
eClinic Stethopod
K220099 · Homediagnostic, LLC · Oct 2022
Eko Murmur Analysis Software (EMAS)
K213794 · Eko Devices, Inc. · Jun 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
K211779 · Chip Ideas Electronics S.L. · May 2022
Smart Wireless Stethoscope
K220470 · Shanghai Hulu Devices Co., Ltd. · May 2022
Steth IO Spot
K220196 · Stratoscientific · Mar 2022