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/productcode/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 154)

Showing 20 most recent of 154 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252915](/device/K252915.md) | AiSteth® | Ai Health Highway India Pvt., Ltd. | May 22, 2026 | SESE |
| [K252089](/device/K252089.md) | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Mar 12, 2026 | SESE |
| [K252076](/device/K252076.md) | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | Feb 6, 2026 | SESE |
| [K252284](/device/K252284.md) | eMurmur Heart AI | Csd Labs | Dec 19, 2025 | SESE |
| [K252595](/device/K252595.md) | Stethophone Pro | Sparrow Acoustics, Inc. | Sep 12, 2025 | SESE |
| [K251494](/device/K251494.md) | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | Aug 12, 2025 | SESE |
| [K242971](/device/K242971.md) | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | Nov 25, 2024 | SESE |
| [K240901](/device/K240901.md) | Stethophone | Sparrow Acoustics, Inc. | Sep 19, 2024 | SESE |
| [K233313](/device/K233313.md) | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | Apr 10, 2024 | SESE |
| [K233609](/device/K233609.md) | CORE 500 Digital Stethoscope | Eko Health, Inc. | Mar 28, 2024 | SESE |
| [K231551](/device/K231551.md) | Stethophone | Sparrow Acoustics, Inc. | Oct 12, 2023 | SESE |
| [K230613](/device/K230613.md) | SKEEPER | Smartsound Corporation | Aug 2, 2023 | SESE |
| [K230823](/device/K230823.md) | AusculThing ACC | Ausculthing OY | Jul 12, 2023 | SESE |
| [K230111](/device/K230111.md) | CORE 500 Digital Stethoscope | Eko Devices, Inc. | May 26, 2023 | SESE |
| [K230769](/device/K230769.md) | PrevisEA Device | Entac Medical, Inc. | May 19, 2023 | SESE |
| [K223785](/device/K223785.md) | N9+ | Nonagon , Ltd. | Apr 14, 2023 | SESE |
| [K222871](/device/K222871.md) | Stethophone v1 | Sparrow Acoustics, Inc. | Mar 29, 2023 | SESE |
| [K221805](/device/K221805.md) | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | Mar 23, 2023 | SESE |
| [K212906](/device/K212906.md) | HeartBuds Electronic Stethoscope | Heartbuds, LLC | Mar 14, 2023 | SESE |
| [K223166](/device/K223166.md) | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | Jan 19, 2023 | 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/productcode/DQD](https://fda.innolitics.com/productcode/DQD)

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