DQD · Stethoscope, Electronic
Cardiovascular · 21 CFR 870.1875 · Class 2
Overview
| Product Code | DQD |
|---|---|
| Device Name | Stethoscope, Electronic |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Mar 12, 2026 | SESE |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | Feb 6, 2026 | SESE |
| K252284 | eMurmur Heart AI | Csd Labs | Dec 19, 2025 | SESE |
| K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | Sep 12, 2025 | SESE |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | Aug 12, 2025 | SESE |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | Nov 25, 2024 | SESE |
| K240901 | Stethophone | Sparrow Acoustics, Inc. | Sep 19, 2024 | SESE |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | Apr 10, 2024 | SESE |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | Mar 28, 2024 | SESE |
| K231551 | Stethophone | Sparrow Acoustics, Inc. | Oct 12, 2023 | SESE |
| K230613 | SKEEPER | Smartsound Corporation | Aug 2, 2023 | SESE |
| K230823 | AusculThing ACC | Ausculthing OY | Jul 12, 2023 | SESE |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | May 26, 2023 | SESE |
| K230769 | PrevisEA Device | Entac Medical, Inc. | May 19, 2023 | SESE |
| K223785 | N9+ | Nonagon , Ltd. | Apr 14, 2023 | SESE |
| K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | Mar 29, 2023 | SESE |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | Mar 23, 2023 | SESE |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | Mar 14, 2023 | SESE |
| K223166 | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | Jan 19, 2023 | SESE |
| K220466 | 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
