DSH · Class II · 21 CFR 870.2800

FDA Product Code DSH: Recorder, Magnetic Tape, Medical

Leading manufacturers include Del Mar Avionics, Bardy Diagnostics, Inc. and Oxford Medilog, Inc..

195
Total
195
Cleared
125d
Avg days
1976
Since
Declining activity - 7 submissions in the last 2 years vs 9 in the prior period
Review times increasing: avg 223d recently vs 121d historically

FDA 510(k) Cleared Recorder, Magnetic Tape, Medical Devices (Product Code DSH)

195 devices
1–24 of 195
Cleared Apr 23, 2026
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K252389
Smwmed, Inc.
Cardiovascular · 266d
Cleared Dec 03, 2025
VitaloJAK Clinic (Model 7100)
K253293
Vitalograph , Ltd.
Anesthesiology · 65d
Cleared Aug 15, 2025
Zio® monitor (DFG0001)
K243650
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 05, 2025
AeviceMD
K243603
Aevice Health Pte. , Ltd.
Anesthesiology · 165d
Cleared May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583
Atsens Co., Ltd.
Cardiovascular · 245d
Cleared Sep 20, 2024
HiCardi+ H100
K232670
MEZOO Co., Ltd.
Cardiovascular · 385d
Cleared Feb 16, 2024
S-Patch (S-Patch ExL)
K233906
Wellysis Corp.
Cardiovascular · 66d
Cleared Nov 27, 2023
ABPMpro
K231104
Somnomedics GmbH
Cardiovascular · 222d
Cleared Nov 22, 2023
Carnation Ambulatory Monitor
K233110
Bardy Diagnostics, Inc.
Cardiovascular · 56d
Cleared Sep 25, 2023
Holter ECG and ABP System
K230184
Edan Instruments, Inc.
Cardiovascular · 245d
Cleared Aug 30, 2023
S-Patch Ex Wearable ECG Patch
K231289
Wellysis Corp.
Cardiovascular · 118d
Cleared Jul 07, 2023
AeviceMD
K223382
Aevice Health Pte. , Ltd.
Anesthesiology · 242d
Cleared Mar 22, 2023
CardioSTAT® ECG Test Solution
K223049
Icentia, Inc.
Cardiovascular · 174d
Cleared Oct 20, 2022
eWave Monitor
K214073
Wearlinq, Inc.
Cardiovascular · 297d
Cleared Oct 12, 2022
AT-Patch ECG Analysis System
K203638
Atsens Co., Ltd.
Cardiovascular · 667d
Cleared Aug 02, 2022
QOCA Portable ECG Monitoring Device
K210179
Quanta Computer, Inc.
Cardiovascular · 557d
Cleared Apr 27, 2022
Strados Remote Electronic Stethoscope Platform (RESP)
K220893
Strados Labs, Inc.
Anesthesiology · 30d
Cleared Jul 20, 2021
LifeLens Wireless ECG Monitor
K203168
LifeLens Technologies, Inc.
Cardiovascular · 270d
Cleared May 21, 2021
Zio Monitor
K202359
iRhythm Technologies, Inc.
Cardiovascular · 275d
Cleared Feb 28, 2021
QardioCore
K201644
Qardio, Inc.
Cardiovascular · 256d
Cleared Feb 05, 2021
Carnation Ambulatory Monitor (CAM)
K210036
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Dec 29, 2020
M5 Recorder
K202456
Global Instrumentation, LLC
Cardiovascular · 124d
Cleared Dec 20, 2020
Strados Remote Electronic Stethoscope Platform (RESP)
K201077
Strados Labs
Anesthesiology · 242d
Cleared Jul 29, 2020
Bioflux Software II
K201040
Biotricity
Cardiovascular · 119d

About Product Code DSH - Regulatory Context

510(k) Submission Activity

195 total 510(k) submissions under product code DSH since 1976, with 195 receiving FDA clearance (average review time: 125 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - DSH Product Code

Recent submissions under DSH have taken an average of 223 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.

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