DXN · Class II · 21 CFR 870.1130

FDA Product Code DXN: System, Measurement, Blood-pressure, Non-invasive

Under FDA product code DXN, non-invasive blood pressure measurement systems are cleared for clinical and ambulatory use.

These devices use oscillometric or auscultatory methods to measure systolic and diastolic blood pressure without arterial puncture. They range from bedside monitors to ambulatory devices that record pressure over 24-hour periods for hypertension diagnosis and management.

DXN devices are Class II medical devices, regulated under 21 CFR 870.1130 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Andon Health Co, Ltd., Health & Life Co., Ltd. and Omron Healthcare, Inc..

1226
Total
1226
Cleared
138d
Avg days
1976
Since
1226 devices
793–816 of 1226
Cleared Jul 27, 2001
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
K012035
Braun GmbH
Cardiovascular · 28d
Cleared Jul 20, 2001
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001
K011310
Nien Made Electrnics Corp.
Cardiovascular · 81d
Cleared Jul 20, 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
K011352
Rossmax International , Ltd.
Cardiovascular · 78d
Cleared Jul 20, 2001
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
K011539
Rossmax International , Ltd.
Cardiovascular · 63d
Cleared Jul 13, 2001
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
K011779
Avid Care Corp.
Cardiovascular · 36d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 28, 2001
HOMMED OBSERVER, MODEL I
K003180
Hommed, LLC
Cardiovascular · 260d
Cleared Jun 14, 2001
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
K011523
Rossmax International , Ltd.
Cardiovascular · 28d
Cleared Jun 11, 2001
BPFONE, MODEL UA 767IT
K010751
Medical Monitors Pty Limited
Cardiovascular · 90d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186
Welch Allyn, Inc.
Cardiovascular · 137d
Cleared May 31, 2001
VASOTRAC APM205A
K011152
Medwave, Inc.
Cardiovascular · 45d
Cleared May 16, 2001
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
K003732
Braun GmbH
Cardiovascular · 163d
Cleared Mar 29, 2001
PRESSURE TRAK, MODEL 222-B
K010622
Suntech Medical Instruments, Inc.
Cardiovascular · 27d
Cleared Mar 29, 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828
A&D Engineering, Inc.
Cardiovascular · 9d
Cleared Mar 20, 2001
WRISTWATCH BLOOD PRESSURE MONITOR A46
K010498
Rossmax Internationl , Ltd.
Cardiovascular · 27d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Feb 08, 2001
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
K010190
Rossmax Internationl , Ltd.
Cardiovascular · 17d
Cleared Jan 29, 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543
Welch Allyn, Inc.
Cardiovascular · 257d
Cleared Jan 29, 2001
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K002791
Unix Electronic Co. , Ltd.
Cardiovascular · 144d
Cleared Dec 15, 2000
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
K003711
Sein Electronics Co., Ltd.
Cardiovascular · 14d
Cleared Nov 21, 2000
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 01, 2000
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
K001948
Hypertension Diagnostics, Inc.
Cardiovascular · 128d