MLO · Class II · 21 CFR 870.2800

FDA Product Code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Leading manufacturers include Inovise Medical, Inc., Agilent Technologies and Zymed Medical Instrumentation.

33
Total
33
Cleared
192d
Avg days
1999
Since
Growing category - 3 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 206d avg (recent)

FDA 510(k) Cleared Electrocardiograph, Ambulatory, With Analysis Algorithm Devices (Product Code MLO)

33 devices
1–24 of 33
Cleared Sep 11, 2026
ZBPro Diagnostic (Version 2.0)
K261580
Zbeats, Inc.
Cardiovascular · 121d
Cleared Mar 21, 2025
Philips Holter Analysis System
K241890
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 266d
Cleared Nov 08, 2024
Frontier X Plus
K240794
Fourth Frontier Technologies Pvt, Ltd.
Cardiovascular · 231d
Cleared Sep 02, 2020
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833
Vivaquant, Inc.
Cardiovascular · 156d
Cleared Aug 26, 2020
CER-S
K193177
Cardiocalm
Cardiovascular · 282d
Cleared Nov 08, 2018
Faros Mobile
K182030
Bittium Biosignals , Ltd.
Cardiovascular · 101d
Cleared Dec 05, 2014
CARDIOSPY ECG HOLTER SYSTEMS
K140847
Labtech Kft.
Cardiovascular · 246d
Cleared Nov 26, 2013
CV3000 HOLTER ANALYSIS SYSTEM
K131897
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 154d
Cleared Oct 11, 2013
AUDICOR CPAM WITH SDB (SINGLE SENSOR)
K130660
Inovise Medical, Inc.
Cardiovascular · 213d
Cleared Sep 20, 2012
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
K120462
Inovise Medical, Inc.
Cardiovascular · 218d
Cleared Nov 10, 2011
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
K111487
Norav Medical Corp.
Cardiovascular · 163d
Cleared Oct 24, 2011
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569
Inovise Medical, Inc.
Cardiovascular · 238d
Cleared Sep 30, 2011
DYNAMIC ECG SYSTEM MODEL TLC5000
K101273
Contec Medical System Co., Ltd.
Cardiovascular · 512d
Cleared Jul 09, 2010
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 296d
Cleared Jun 29, 2007
MEDICK MHM200 PERSONAL HEART MONITOR
K063339
Medick Healthcare , Ltd.
Cardiovascular · 235d
Cleared Aug 25, 2006
PREMIER 11 HOLTER
K062088
Diagnostic Monitoring Software
Cardiovascular · 32d
Cleared Sep 26, 2005
MATRIX HOLTER SYSTEM, MODEL M12
K051730
Global Instrumentation, LLC
Cardiovascular · 91d
Cleared Sep 02, 2005
SEER MC
K042782
Ge Medical Systems Information Technologies
Cardiovascular · 331d
Cleared Mar 24, 2005
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454
Medicomp, Inc.
Cardiovascular · 99d
Cleared Jan 19, 2005
VISTA PLUS
K042108
Novacor
Cardiovascular · 168d
Cleared May 08, 2002
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
K012712
Norav Medical , Ltd.
Cardiovascular · 267d
Cleared Oct 04, 2001
C. NET 2100
K010396
Cardionetics, Ltd.
Cardiovascular · 237d
Cleared Sep 28, 2001
2010 PLUS HOLTER FOR WINDOWS
K010949
Agilent Technologies
Cardiovascular · 183d
Cleared Jun 11, 2001
H-SCRIBE
K004017
Mortara Instrument, Inc.
Cardiovascular · 166d

About Product Code MLO - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code MLO since 1999, with 33 receiving FDA clearance (average review time: 192 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MLO Product Code

FDA review times for MLO submissions have been consistent, averaging 206 days recently vs 191 days historically.

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