MWJ · Class II · 21 CFR 870.2800

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

Leading manufacturers include Mortara Instrument, Inc., Spacelabs Healthcare, Ltd. and Biotricity.

61
Total
61
Cleared
145d
Avg days
1998
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 377d recently vs 133d historically

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

61 devices
1–24 of 61
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 Feb 26, 2016
H3+ Holter Recorder
K152626
Mortara Instrument, Inc.
Cardiovascular · 164d
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 May 19, 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731
Ge Medical Systems Information Technologies
Cardiovascular · 59d
Cleared Feb 25, 2005
HOLTER RECORDER H3+
K043010
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Aug 22, 2003
SPIDERVIEW
K032466
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470
General Electric Medical Systems Information Techn
Cardiovascular · 190d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373
Mortara Instrument, Inc.
Cardiovascular · 57d

About Product Code MWJ - Regulatory Context

510(k) Submission Activity

61 total 510(k) submissions under product code MWJ since 1998, with 61 receiving FDA clearance (average review time: 145 days).

Submission volume has increased in recent years - 3 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 377 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 →