DQD · Class II · 21 CFR 870.1875

FDA Product Code DQD: Stethoscope, Electronic

Leading manufacturers include 3M Company, Chip Ideas Electronics S.L. and Eko Devices, Inc..

156
Total
156
Cleared
140d
Avg days
1977
Since
Declining activity - 9 submissions in the last 2 years vs 15 in the prior period
Consistent review times: 133d avg (recent)

FDA 510(k) Cleared Stethoscope, Electronic Devices (Product Code DQD)

156 devices
1–24 of 156
Cleared Jul 31, 2026
Smart Wireless Stethoscope (STEMO310)
K261494
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 86d
Cleared Jul 23, 2026
CORE 300 Digital Stethoscope
K261694
Eko Health, Inc.
Cardiovascular · 62d
Cleared May 22, 2026
AiSteth®
K252915
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared Mar 12, 2026
Tyto Stethoscope (G3)
K252089
Tyto Care , Ltd.
Cardiovascular · 253d
Cleared Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076
Kneevoice, Inc.
Cardiovascular · 219d
Cleared Dec 19, 2025
eMurmur Heart AI
K252284
Csd Labs
Cardiovascular · 150d
Cleared Sep 12, 2025
Stethophone Pro
K252595
Sparrow Acoustics, Inc.
Cardiovascular · 28d
Cleared Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494
Eko Health, Inc.
Cardiovascular · 89d
Cleared Nov 25, 2024
AccurSound Electronic Stethoscope (AS101)
K242971
Heroic Faith International , Ltd.
Cardiovascular · 60d
Cleared Sep 19, 2024
Stethophone
K240901
Sparrow Acoustics, Inc.
Cardiovascular · 170d
Cleared Apr 10, 2024
Keikku Electronic stethoscope
K233313
Lapsi Health Holding B.V.
Cardiovascular · 194d
Cleared Mar 28, 2024
CORE 500 Digital Stethoscope
K233609
Eko Health, Inc.
Cardiovascular · 136d
Cleared Oct 12, 2023
Stethophone
K231551
Sparrow Acoustics, Inc.
Cardiovascular · 135d
Cleared Aug 02, 2023
SKEEPER
K230613
Smartsound Corporation
Cardiovascular · 149d
Cleared Jul 12, 2023
AusculThing ACC
K230823
Ausculthing OY
Cardiovascular · 110d
Cleared May 26, 2023
CORE 500 Digital Stethoscope
K230111
Eko Devices, Inc.
Cardiovascular · 129d
Cleared May 19, 2023
PrevisEA Device
K230769
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 14, 2023
N9+
K223785
Nonagon , Ltd.
Cardiovascular · 119d
Cleared Mar 29, 2023
Stethophone v1
K222871
Sparrow Acoustics, Inc.
Cardiovascular · 188d
Cleared Mar 23, 2023
AccurSound Electronic Stethoscope AS-101
K221805
Heroic Faith International , Ltd.
Cardiovascular · 274d
Cleared Mar 14, 2023
HeartBuds Electronic Stethoscope
K212906
Heartbuds, LLC
Cardiovascular · 547d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166
Medaica, Inc.
Cardiovascular · 104d
Cleared Nov 03, 2022
ibiomedi Electronic Stethoscope ES-2020
K220466
Sound Land Corp.
Cardiovascular · 259d
Cleared Oct 20, 2022
eClinic Stethopod
K220099
Homediagnostic, LLC
Cardiovascular · 281d

About Product Code DQD - Regulatory Context

510(k) Submission Activity

156 total 510(k) submissions under product code DQD since 1977, with 156 receiving FDA clearance (average review time: 140 days).

Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 15 in the prior period.

FDA 510(k) Review Time - DQD Product Code

FDA review times for DQD submissions have been consistent, averaging 133 days recently vs 140 days historically.

DQD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →