HD Steth
FDA 510(k) clearance K201299 · decided 2020-07-10
Clearance details
- K-number
- K201299
- Device name
- HD Steth
- Applicant
- Hd Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-15
- Decision date
- 2020-07-10
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DQD
- Device class
- 2
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 Labs | 2025-12-19 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.