DXH · Class II · 21 CFR 870.2920

FDA Product Code DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Leading manufacturers include Card Guard Scientific Survival , Ltd., Medtronic Vascular and AliveCor, Inc..

297
Total
297
Cleared
145d
Avg days
1976
Since
Growing category - 5 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 337d recently vs 142d historically

FDA 510(k) Cleared Transmitters And Receivers, Electrocardiograph, Telephone Devices (Product Code DXH)

297 devices
1–24 of 297
Cleared Feb 13, 2026
PreemptiveAI Clinical SDK
K250233
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Cardiovascular · 382d
Cleared Dec 08, 2025
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
K250258
Heartbeam, Inc.
Cardiovascular · 314d
Cleared Dec 05, 2025
MEMO Patch M (MPT-E08R-UNC01)
K243438
Huinno Co., Ltd.
Cardiovascular · 394d
Cleared Nov 18, 2025
Hexoskin Medical System (7100-00016)
K243981
Carre Technologies, Inc.
Cardiovascular · 330d
Cleared Jun 17, 2025
VitalSigns 1-Lead Holter (VSH101)
K243003
VitalSigns Technology Co., Ltd.
Cardiovascular · 264d
Cleared Dec 06, 2023
QT ECG (QTERD100)
K233521
QT Medical, Inc.
Cardiovascular · 35d
Cleared Oct 20, 2022
V-Patch Cardiac Monitor
K222842
Shandong Corecare Technology Limited
Cardiovascular · 30d
Cleared Sep 26, 2022
QT ECG
K220795
QT Medical, Inc.
Cardiovascular · 192d
Cleared Jul 19, 2022
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
K213357
Verily Life Sciences, LLC
Cardiovascular · 280d
Cleared May 25, 2022
KardiaMobile 6L
K220350
AliveCor, Inc.
Cardiovascular · 107d
Cleared Nov 30, 2021
KardiaMobile Card
K211668
AliveCor, Inc.
Cardiovascular · 182d
Cleared Sep 22, 2021
SimpleSENSE Platform
K212160
Nanowear, Inc.
Cardiovascular · 72d
Cleared Jun 30, 2021
KardiaMobile 6L
K210753
AliveCor, Inc.
Cardiovascular · 107d
Cleared Nov 06, 2020
SimpleSENSE
K201669
Nanowear, Inc.
Cardiovascular · 140d
Cleared Oct 30, 2020
eCordum Cardiac Monitor (eCordum CM)
K193296
Ecordum, Inc.
Cardiovascular · 338d
Cleared Sep 23, 2020
Halo AF Detection System
K201208
Livmor
Cardiovascular · 141d
Cleared Jan 24, 2020
KardiaMobile, KardiaStation
K191406
AliveCor, Inc.
Cardiovascular · 241d
Cleared Jan 17, 2020
Study Watch with Irregular Pulse Monitor
K192415
Verily Life Sciences, LLC
Cardiovascular · 135d
Cleared May 10, 2019
Triangle System
K183319
AliveCor, Inc.
Cardiovascular · 161d
Cleared Apr 12, 2019
KardiaMobile, KardiaStation
K182396
AliveCor, Inc.
Cardiovascular · 220d
Cleared Feb 22, 2019
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
K181310
Cardiocomm Solutions, Inc.
Cardiovascular · 281d
Cleared Feb 16, 2019
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704
Vivaquant, Inc.
Cardiovascular · 47d
Cleared Feb 08, 2019
Coala Heart Monitor
K182040
Coala Life AB
Cardiovascular · 193d
Cleared Jan 17, 2019
Study Watch
K182456
Verily Life Sciences, LLC
Cardiovascular · 132d

About Product Code DXH - Regulatory Context

510(k) Submission Activity

297 total 510(k) submissions under product code DXH since 1976, with 297 receiving FDA clearance (average review time: 145 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXH Product Code

Recent submissions under DXH have taken an average of 337 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.

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