MWJ · Class II · 21 CFR 870.2800

FDA Product Code MWJ: Electrocardiograph, Ambulatory (without Analysis)

Leading manufacturers include Getemed Medizin- Und Informationstechnik AG, North East Monitoring, Inc. and Braemar, Inc..

62
Total
62
Cleared
147d
Avg days
1998
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 350d recently vs 133d historically

FDA 510(k) Cleared Electrocardiograph, Ambulatory (without Analysis) Devices (Product Code MWJ)

62 devices
1–24 of 62
Cleared Aug 14, 2026
medilogFD
K253562
Schiller AG
Cardiovascular · 270d
Cleared Jun 25, 2026
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
K253384
Seers Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 18, 2026
ZywieZ3 Sensor & Adhesive
K252839
Zywie, Inc.
Cardiovascular · 286d
Cleared Dec 13, 2024
HeartBeam AIMIGo(TM) System
K231424
Heartbeam, Inc.
Cardiovascular · 576d
Cleared May 07, 2024
ASSURE Wearable ECG
K233864
Kestra Medical Technologies, Inc.
Cardiovascular · 153d
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Jul 28, 2022
Biotres
K222017
Biotricity
Cardiovascular · 20d
Cleared Jun 02, 2022
Q Patch
K210758
Medicalgorithmics S.A.
Cardiovascular · 444d
Cleared Jan 19, 2022
Biotres
K211709
Biotricity
Cardiovascular · 230d
Cleared Nov 22, 2021
Eclipse PRO
K211651
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Jun 08, 2018
Integrated CardioRespiratory System
K173156
Sensydia, Inc.
Cardiovascular · 252d
Cleared Jun 13, 2016
NR Recorder
K161062
Norav Medical GmbH
Cardiovascular · 59d
Cleared Feb 26, 2016
H3+ Holter Recorder
K152626
Mortara Instrument, Inc.
Cardiovascular · 164d
Cleared Nov 25, 2014
DR300 HOLTER MONITOR
K142424
North East Monitoring, Inc.
Cardiovascular · 88d
Cleared May 19, 2014
DMS 300-2W HOLTER ECG RECORDER
K133014
Diagnostic Monitoring Software
Cardiovascular · 236d
Cleared Oct 16, 2013
BRAEMAR CARDIOKEY HOLTER RECORDER
K130294
Braemar Manufacturing, LLC
Cardiovascular · 252d
Cleared Jul 26, 2013
SEER 1000
K130785
Getemed Medizin- Und Informationstechnik AG
Cardiovascular · 127d
Cleared Mar 28, 2013
CARDIOMEM
K122272
Getemed Medizin- Und Informationstechnik AG
Cardiovascular · 241d
Cleared Mar 22, 2012
EZSLEEP SLEEP QUALITY RECORDER
K112573
Platinum Team Co., Ltd.
Cardiovascular · 198d
Cleared Nov 09, 2011
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
K112601
Intricon Datrix Corporation
Cardiovascular · 63d
Cleared Oct 13, 2010
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
K100310
BTL Industries, Inc.
Cardiovascular · 252d
Cleared Aug 13, 2009
CHROMA, MODEL: RZ153C
K083382
Scottcare Corporation
Cardiovascular · 272d
Cleared Sep 09, 2008
AUDICOR, HEMO AMBULATORY MONITOR
K073545
Inovise Medical, Inc.
Cardiovascular · 266d
Cleared Oct 03, 2007
E3-80 PORTABLE ECG RECORDER & ANALYZER
K071085
Micro-Star International Co., Ltd.
Cardiovascular · 169d

About Product Code MWJ - Regulatory Context

510(k) Submission Activity

62 total 510(k) submissions under product code MWJ since 1998, with 62 receiving FDA clearance (average review time: 147 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MWJ Product Code

Recent submissions under MWJ have taken an average of 350 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

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