Atlas FDA

DQD

156 FDA 510(k) clearances · Product code

122 daysmedian time to decision
259 days90th percentile
156clearances measured

FDA profile

Official device name
Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) (K261494)Shanghai Hulu Devices Co., Ltd.2026-07-31
CORE 300 Digital Stethoscope (K261694)Eko Health, Inc.2026-07-23
AiSteth® (K252915)Ai Health Highway India Pvt., Ltd.2026-05-22
Tyto Stethoscope (G3) (K252089)Tyto Care , Ltd.2026-03-12
Kneevoice Cartilage Evaluation System (750-3600-001) (K252076)Kneevoice, Inc.2026-02-06
eMurmur Heart AI (K252284)Csd Labs2025-12-19
Stethophone Pro (K252595)Sparrow Acoustics, Inc.2025-09-12
Eko Foundation Analysis Software with Transformers (EFAST) (K251494)Eko Health, Inc.2025-08-12
AccurSound Electronic Stethoscope (AS101) (K242971)Heroic Faith International , Ltd.2024-11-25
Stethophone (K240901)Sparrow Acoustics, Inc.2024-09-19
Keikku Electronic stethoscope (K233313)Lapsi Health Holding B.V.2024-04-10
CORE 500 Digital Stethoscope (K233609)Eko Health, Inc.2024-03-28
Stethophone (K231551)Sparrow Acoustics, Inc.2023-10-12
SKEEPER (K230613)Smartsound Corporation2023-08-02
AusculThing ACC (K230823)Ausculthing OY2023-07-12
CORE 500 Digital Stethoscope (K230111)Eko Devices, Inc.2023-05-26
PrevisEA Device (K230769)Entac Medical, Inc.2023-05-19
N9+ (K223785)Nonagon , Ltd.2023-04-14
Stethophone v1 (K222871)Sparrow Acoustics, Inc.2023-03-29
AccurSound Electronic Stethoscope AS-101 (K221805)Heroic Faith International , Ltd.2023-03-23
HeartBuds Electronic Stethoscope (K212906)Heartbuds, LLC2023-03-14
Medaica M1 Telehealth Stethoscope (K223166)Medaica, Inc.2023-01-19
ibiomedi Electronic Stethoscope ES-2020 (K220466)Sound Land Corp.2022-11-03
eClinic Stethopod (K220099)Homediagnostic, LLC2022-10-20
Eko Murmur Analysis Software (EMAS) (K213794)Eko Devices, Inc.2022-06-29
eMurmur Heart AI (K220766)Csd Labs GmbH2022-05-31
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.2022-05-26
Smart Wireless Stethoscope (K220470)Shanghai Hulu Devices Co., Ltd.2022-05-23
Steth IO Spot (K220196)Stratoscientific2022-03-24
VoqX Electronic Stethoscope (K212709)Sanolla , Ltd.2022-03-15
eKuore Pro 4T - REF EP0098 (K212013)Chip Ideas Electronics S.L.2021-11-10
PrevisEA Device (K211068)Entac Medical, Inc.2021-08-04
doctorgram Stethoscope DES-I (K210736)Gv Concepts2021-07-27
MyHomeDoc (K202483)Myhomedoc , Ltd.2021-03-23
eKuore One Wireless Electronic Interface for stethoscope (K201742)Chip Ideas Electronics S.L.2020-11-24
eKuore Pro Series (K203007)Chip Ideas Electronics S.L.2020-10-30
Stethee Pro 1, Stethee Pro Software System (K193631)M3Dicine Pty , Ltd.2020-10-09
Feelix Stethoscope (K200862)Sonavi Labs, Inc.2020-09-14
HD Steth (K201299)Hd Medical, Inc.2020-07-10
Eko CORE (K200776)Eko Devices, Inc.2020-04-06
Electronic Stethoscope (K191667)Hefei Mintti Medical Technology Co., Ltd. China2019-12-18
Vivio System (K183710)Avicena, LLC2019-10-04
eMurmur ID (K181988)Csd Labs GmbH2019-04-17
eKuore One electronic interface for stethoscope (K181882)Chip Ideas Electronics S.L.2019-03-27
Tyto Stethoscope (OTC) (K181612)Tyto Care , Ltd.2018-12-17
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (K182196)Imediplus, Inc.2018-09-11
Electronic Stethoscope DS3011A (K173663)Imediplus, Inc.2018-08-17
CliniCloud Stethoscope (K173448)Stethocloud Pty.Ltd (Clinicloud)2018-01-25
Stethee Pro (K172296)M3Dicine Pty , Ltd.2017-10-30
CADence System (K170928)Aum Cardiovascular, Inc.2017-08-03
Eko Model E5 System (EME5), Eko DUO (K170874)Eko Devices, Inc.2017-05-19
Adscope 658 Electronic Stethoscope (K162589)American Diagnostic Corp.2017-03-10
Tyto Stethoscope (K160401)Tyto Care , Ltd.2016-10-19
Electronic Stethoscope DS301 (K160023)Imediplus, Inc.2016-09-30
Steth IO (K160016)Stratoscientific, Inc.2016-07-15
AbStats Gateway (K150782)Gi Logic, Inc.2015-12-14
Eko Electronic Stethoscope System (K151319)Eko Devices, Inc.2015-08-28
PARACE MD EKOSCOPE IS100 (K123148)Parace, LLC2013-11-19
PPA/BT-RB STETHOSCOPE (K132405)Rnk Products, Inc.2013-10-11
PCP-USB STETHOSCOPE (K132560)Rnk Products, Inc.2013-10-11
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION (K131044)Diacoustic Medical Devices (Pty) , Ltd.2013-09-04
CARDIOSLEEVE (K131287)Rijuven Corp2013-06-24
ELECTRONIC STETHOSCOPE (K121144)Sharp Corporation2012-09-26
SENSICARDIAC (K121617)Diacoustic Medical (Pty)2012-07-27
SENSI (K110704)Diacoustic Medical Devices (Pty) , Ltd.2011-06-24
A SCOPE (K103499)Active Signal Technologies, Inc.2011-03-31
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 (K103516)Inovise Medical, Inc.2011-02-04
PCP/PC STETHOSCOPE (K102893)Rnk Products, Inc.2011-01-20
VISCOPE, MODEL 100P,100S (K100531)Hd Medical Services (India) Pvt.Ltd2010-07-21
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 (K091972)Stethoscope Technologies, Inc.2009-09-23
SIGNAL (K090493)Zargis Medical Corp.2009-08-07
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 (K083903)3M Company2009-07-15
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM (K082528)Noble Anesthesia-Air, Inc.2009-03-06
PROTRON TECHNOLOGIES, LLC STETHOTRON (K082771)Protron Technologies, LLC2009-02-27
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 (K083309)Zargis Medical Corp.2009-02-13
TR-USB TELEPHONIC STETHOSCOPE (K081032)Rnk Products, Inc.2008-06-06
AUSCO ES-3100 (K070550)Koratek Company, Ltd.2007-11-06
RNK ELECTRONIC STETHOSCOPE (K072026)Rnk Products, Inc.2007-10-26
I-SCOPE 200 (K062364)Dongjin Medical Co., Ltd.2006-12-06
SERENO ELECTRONIC STETHOSCOPE (K062481)Pishon High Tech Co., Ltd.2006-10-16
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (K060321)American Diagnostic Corp.2006-05-15
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 (K060197)Zargis Medical Corp.2006-03-29
HEART STG SYSTEM AND SOFTWARE (K052283)Stethographics, Inc.2005-12-23
EXTENDED MEASUREMENTS SYSTEM (K051450)Inovise Medical, Inc.2005-11-10
TECHNO-SCOPE VISUAL STETHOSCOPE (K050097)Techtrade, LLC2005-09-30
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 (K051790)3M Company2005-07-25
HL 200 ELECTRONIC STETHOSCOPE (K050169)Health & Life Co., Ltd.2005-04-05
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 (K050159)3M Company2005-02-22
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 (K041934)3M Company2004-10-15
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) (K042128)Zargis Medical Corp.2004-09-08
ZARGIS ACOUSTIC CARDIOSCAN (K031517)Zargis Medical Corp.2004-05-26
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 (K034046)Rnk Products2004-03-10
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE (K032230)Thinklabs, Inc.2003-11-26
JABES ELECTRONIC STETHOSCOPE (K031446)Gs Technology Co., Ltd.2003-10-31
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER (K023759)Sonomedica2003-05-06
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) (K023637)Tytan Medical Corp.2003-02-26
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE (K021087)Erecords Limited2002-10-11
I-STETHOS LINK (K022298)Andromed, Inc.2002-10-01
BIOLOGICAL SOUND MONITOR (BSM) SENSOR (K021389)Andromed, Inc.2002-10-01
MEDITRON II THESTERTHOSCOPE SYSTEM (K013725)Meditron AS2002-01-30
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