DQD
- Product code
- DQD
- Device name
- Stethoscope, Electronic
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1875
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 13
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 156 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261494 | 2026-07-31 | Shanghai Hulu Devices Co., Ltd. | Smart Wireless Stethoscope (STEMO310);Smart Wireless… | FDA |
| K261694 | 2026-07-23 | Eko Health, Inc. | CORE 300 Digital Stethoscope | |
| K252915 | 2026-05-22 | Ai Health Highway India Pvt., Ltd. | AiSteth® | |
| K252089 | 2026-03-12 | Tyto Care , Ltd. | Tyto Stethoscope (G3) | |
| K252076 | 2026-02-06 | Kneevoice, Inc. | Kneevoice Cartilage Evaluation System (750-3600-001) | |
| K252284 | 2025-12-19 | Csd Labs | eMurmur Heart AI | |
| K252595 | 2025-09-12 | Sparrow Acoustics, Inc. | Stethophone Pro | |
| K251494 | 2025-08-12 | Eko Health, Inc. | Eko Foundation Analysis Software with Transformers (… | |
| K242971 | 2024-11-25 | Heroic Faith International , Ltd. | AccurSound Electronic Stethoscope (AS101) | |
| K240901 | 2024-09-19 | Sparrow Acoustics, Inc. | Stethophone | |
| K233313 | 2024-04-10 | Lapsi Health Holding B.V. | Keikku Electronic stethoscope | |
| K233609 | 2024-03-28 | Eko Health, Inc. | CORE 500 Digital Stethoscope | |
| K231551 | 2023-10-12 | Sparrow Acoustics, Inc. | Stethophone |
Official FDA classification page: DQD
Classification and pathway per current FDA publications. Data from openFDA (CC0).