System, Measurement, Blood-pressure, Non-invasive

Device Code: 821

Product Code(s): DXN

Device Classification Information

Device Type ID821
Device NameSystem, Measurement, Blood-pressure, Non-invasive
Regulation DescriptionNoninvasive Blood Pressure Measurement System.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.1130 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDXN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID821
DeviceSystem, Measurement, Blood-pressure, Non-invasive
Product CodeDXN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNoninvasive Blood Pressure Measurement System.
CFR Regulation Number870.1130 [🔎]
Premarket Reviews
ManufacturerDecision
A & D
 
SUBSTANTIALLY EQUIVALENT
 3
A&D COMPANY, LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
ANDON HEALTH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
ANDON HEALTH CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
 11
AVITA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
BIOCARE ASIA CORPORATION LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
EDWARDS LIFESCIENCES
 
SUBSTANTIALLY EQUIVALENT
 3
EDWARDS LIFESCIENCES LLC
 
SUBSTANTIALLY EQUIVALENT
 1
EDWARDS LIFESCIENCES, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ENGAGEMENTHEALTH, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FINAPRES MEDICAL SYSTEMS B.V.
 
SUBSTANTIALLY EQUIVALENT
 1
FINAPRES MEDICAL SYSTEMS BV
 
SUBSTANTIALLY EQUIVALENT
 2
FORA CARE INC.
 
SUBSTANTIALLY EQUIVALENT
 1
FUTREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBAL INSTRUMENTATION, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
 
SUBSTANTIALLY EQUIVALENT
 15
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
HEALTH & LIFE CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 6
HEALTH & LIFE CO., LTD. (TAIWAN)
 
SUBSTANTIALLY EQUIVALENT
 6
HEALTHCHEK NETWORK, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
HEALTHSTATS INTERNATIONAL PTE. LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
HIGI SH LLC
 
SUBSTANTIALLY EQUIVALENT
 2
I.E.M. GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
INTEGRATED DISPLAY TECHNOLOGY, LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
JAWON MEDICAL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
LD TECHNOLOGY LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDIANA CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDIANATECHNOLOGIES CORP
 
SUBSTANTIALLY EQUIVALENT
 9
METRO DESIGN USA
 
SUBSTANTIALLY EQUIVALENT
 2
MICROLIFE
 
SUBSTANTIALLY EQUIVALENT
 10
MICROLIFE INTELLECTUAL PROPERTY GMBH
 
SUBSTANTIALLY EQUIVALENT
 10
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND
 
SUBSTANTIALLY EQUIVALENT
 3
MORTARA
 
SUBSTANTIALLY EQUIVALENT
 1
MORTARA INSTRUMENT, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
OMRON HEALTHCARE, INC
 
SUBSTANTIALLY EQUIVALENT
 1
OMRON HEALTHCARE, INC.
 
SUBSTANTIALLY EQUIVALENT
 9
PAR MEDIZINTECHNIK GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
QARDIO, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 5
SHENZHEN JIACOM TECHNOLOGY CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
SHENZHEN URION TECHNOLOGY CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN URION TECHNOLOGY CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SKANRAY TECHNOLOGIES PVT LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SPACELABS HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 1
SPACELABS HEALTHCARE LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SUNTECH MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SUZHOU SUNSPIRIT CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
TAIDOC TECHNOLOGY CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
TRULY INSTRUMENT LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
VISIOMED GROUP SA
 
SUBSTANTIALLY EQUIVALENT
 1
WITHINGS
 
SUBSTANTIALLY EQUIVALENT
 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 2
Device Problems
Device Operational Issue
 391
Incorrect, Inadequate Or Imprecise Result Or Readings
 244
Device Displays Incorrect Message
213
Output Problem
 208
Device Operates Differently Than Expected
 199
Incorrect Or Inadequate Test Results
 170
High Test Results
 113
Low Readings
 39
Incorrect Measurement
 36
No Device Output
19
Failure To Pump
 17
Break
 12
High Readings
 9
Bolt
 8
Inflation Problem
 5
Physical Property Issue
 5
Mechanical Problem
 5
Leak / Splash
 5
Improper Alarm
 4
Pumping Problem
 4
Malposition Of Device
3
Electrical /Electronic Property Problem
 3
Invalid Sensing
 3
Sparking
 3
Infusion Or Flow Problem
 3
Battery Problem
 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally
 3
Power Problem
 3
Improper Device Output
 2
Issue With Displayed Error Message
 2
Fire
 2
Adverse Event Without Identified Device Or Use Problem
 2
No Audible Alarm
 2
Smoking
 2
Detachment Of Device Or Device Component
 2
Device Issue
 2
Decrease In Pressure
 2
Low Test Results
 1
Device Contamination With Chemical Or Other Material
 1
No Pressure
 1
Unintended Collision
 1
Monitor
 1
Image Display Error / Artifact
 1
Application Program Problem
 1
Excess Flow Or Over-Infusion
 1
Failure To Shut Off
 1
Defective Device
 1
Display Or Visual Feedback Problem
 1
Overheating Of Device
 1
Speaker
 1
Defective Alarm
 1
Erratic Or Intermittent Display
 1
Component Missing
1
No Display / Image
 1
Cuff
 1
Mount
 1
Screen
 1
Operating System Becomes Nonfunctional
 1
Device Stops Intermittently
 1
Device Inoperable
 1
Total Device Problems 1771
Recalls
Manufacturer Recall Class Date Posted
1
A & D Enginering Inc
 II Oct-09-2016
2
Edwards Lifesciences, LLC
 II Jun-09-2015
3
Welch Allyn Inc
 II Apr-11-2017
4
Withings Sas
 II Aug-16-2018
TPLC Last Update: 2019-04-02 19:42:24
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