FDA Product Code DQD: Stethoscope, Electronic
Leading manufacturers include Sparrow Acoustics, Inc., Eko Health, Inc. and Eko Devices, Inc..
153
Total
153
Cleared
140d
Avg days
1977
Since
Declining activity -
7 submissions in the last 2 years
vs 18 in the prior period
Consistent review times:
138d avg (recent)
FDA 510(k) Cleared Stethoscope, Electronic Devices (Product Code DQD)
153 devices
Cleared
Mar 12, 2026
Tyto Stethoscope (G3)
Tyto Care , Ltd.
Cardiovascular
253d
Cleared
Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
Kneevoice, Inc.
Cardiovascular
219d
Cleared
Dec 19, 2025
eMurmur Heart AI
Csd Labs
Cardiovascular
150d
Cleared
Sep 12, 2025
Stethophone Pro
Sparrow Acoustics, Inc.
Cardiovascular
28d
Cleared
Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
Eko Health, Inc.
Cardiovascular
89d
Cleared
Nov 25, 2024
AccurSound Electronic Stethoscope (AS101)
Heroic Faith International , Ltd.
Cardiovascular
60d
Cleared
Sep 19, 2024
Stethophone
Sparrow Acoustics, Inc.
Cardiovascular
170d
Cleared
Apr 10, 2024
Keikku Electronic stethoscope
Lapsi Health Holding B.V.
Cardiovascular
194d
Cleared
Mar 28, 2024
CORE 500 Digital Stethoscope
Eko Health, Inc.
Cardiovascular
136d
Cleared
Oct 12, 2023
Stethophone
Sparrow Acoustics, Inc.
Cardiovascular
135d
Cleared
Aug 02, 2023
SKEEPER
Smartsound Corporation
Cardiovascular
149d
Cleared
Jul 12, 2023
AusculThing ACC
Ausculthing OY
Cardiovascular
110d
Cleared
May 26, 2023
CORE 500 Digital Stethoscope
Eko Devices, Inc.
Cardiovascular
129d
Cleared
May 19, 2023
PrevisEA Device
Entac Medical, Inc.
Gastroenterology & Urology
60d
Cleared
Apr 14, 2023
N9+
Nonagon , Ltd.
Cardiovascular
119d
Cleared
Mar 29, 2023
Stethophone v1
Sparrow Acoustics, Inc.
Cardiovascular
188d
Cleared
Mar 23, 2023
AccurSound Electronic Stethoscope AS-101
Heroic Faith International , Ltd.
Cardiovascular
274d
Cleared
Mar 14, 2023
HeartBuds Electronic Stethoscope
Heartbuds, LLC
Cardiovascular
547d
Cleared
Jan 19, 2023
Medaica M1 Telehealth Stethoscope
Medaica, Inc.
Cardiovascular
104d
Cleared
Jun 29, 2022
Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc.
Cardiovascular
205d
Cleared
May 26, 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
Chip Ideas Electronics S.L.
Cardiovascular
351d
About Product Code DQD - Regulatory Context
510(k) Submission Activity
153 total 510(k) submissions under product code DQD since 1977, with 153 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 18 in the prior period.
FDA Review Time
FDA review times for DQD submissions have been consistent, averaging 138 days recently vs 140 days historically.
DQD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →