Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875) → DQD — Stethoscope, Electronic # DQD · Stethoscope, Electronic _Cardiovascular · 21 CFR 870.1875 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD ## Overview - **Product Code:** DQD - **Device Name:** Stethoscope, Electronic - **Regulation:** [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs. ## Classification Rationale Manual stethoscope: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. Electronic stethoscope: Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 153) Showing 20 most recent of 153 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252089](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K252089.md) | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Mar 12, 2026 | SESE | | [K252076](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K252076.md) | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | Feb 6, 2026 | SESE | | [K252284](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K252284.md) | eMurmur Heart AI | Csd Labs | Dec 19, 2025 | SESE | | [K252595](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K252595.md) | Stethophone Pro | Sparrow Acoustics, Inc. | Sep 12, 2025 | SESE | | [K251494](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K251494.md) | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | Aug 12, 2025 | SESE | | [K242971](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K242971.md) | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | Nov 25, 2024 | SESE | | [K240901](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K240901.md) | Stethophone | Sparrow Acoustics, Inc. | Sep 19, 2024 | SESE | | [K233313](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K233313.md) | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | Apr 10, 2024 | SESE | | [K233609](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K233609.md) | CORE 500 Digital Stethoscope | Eko Health, Inc. | Mar 28, 2024 | SESE | | [K231551](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K231551.md) | Stethophone | Sparrow Acoustics, Inc. | Oct 12, 2023 | SESE | | [K230613](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K230613.md) | SKEEPER | Smartsound Corporation | Aug 2, 2023 | SESE | | [K230823](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K230823.md) | AusculThing ACC | Ausculthing OY | Jul 12, 2023 | SESE | | [K230111](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K230111.md) | CORE 500 Digital Stethoscope | Eko Devices, Inc. | May 26, 2023 | SESE | | [K230769](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K230769.md) | PrevisEA Device | Entac Medical, Inc. | May 19, 2023 | SESE | | [K223785](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K223785.md) | N9+ | Nonagon , Ltd. | Apr 14, 2023 | SESE | | [K222871](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K222871.md) | Stethophone v1 | Sparrow Acoustics, Inc. | Mar 29, 2023 | SESE | | [K221805](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K221805.md) | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | Mar 23, 2023 | SESE | | [K212906](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K212906.md) | HeartBuds Electronic Stethoscope | Heartbuds, LLC | Mar 14, 2023 | SESE | | [K223166](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K223166.md) | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | Jan 19, 2023 | SESE | | [K220466](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K220466.md) | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | Nov 3, 2022 | SESE | ## Top Applicants - 3M Company — 6 clearances - Chip Ideas Electronics S.L. — 5 clearances - Eko Devices, Inc. — 5 clearances - Rnk Products, Inc. — 5 clearances - Zargis Medical Corp. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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