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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, measurement, blood-pressure, non-invasive
Regulation Description Noninvasive blood pressure measurement system.
Product CodeDXN
Regulation Number 870.1130
Device Class 2


Premarket Reviews
ManufacturerDecision
A & D
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 43
ATCOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUTOMATED SCREENING DEVICES
  SUBSTANTIALLY EQUIVALENT 2
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND
  SUBSTANTIALLY EQUIVALENT 1
BMEYE B.V.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BRISTOLINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CALHEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOCOM LLC
  SUBSTANTIALLY EQUIVALENT 3
CAREMATIX INC.
  SUBSTANTIALLY EQUIVALENT 2
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
CNSYSTEM MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 5
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
FEGO PRECISION INDUSTRIAL CO; LTD
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GENEXEL-SEIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARVARD MEDICAL DEVICES LTD.
  SUBSTANTIALLY EQUIVALENT 3
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 45
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHSTATS INTERNATIONAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 6
HEALTHTEAM
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED LLC
  SUBSTANTIALLY EQUIVALENT 1
HONEYWELL HOMMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
I.E.M. GMBH
  SUBSTANTIALLY EQUIVALENT 4
IDEAL LIFE INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JAWON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KING YIELD HONGKONG LIMITED
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
  SUBSTANTIALLY EQUIVALENT 9
LITTLE DOCTOR
  SUBSTANTIALLY EQUIVALENT 2
MABIS
  SUBSTANTIALLY EQUIVALENT 1
MARCH HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 3
MARS MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWAVE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICROLIFE
  SUBSTANTIALLY EQUIVALENT 28
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
MYTECH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
NIHON SEIMITSU SOKKI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 18
NONIN
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 26
OSTAR MEDITECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
PHARMASMART, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 5
QRS
  SUBSTANTIALLY EQUIVALENT 2
QUANTA COMPUTER INC.
  SUBSTANTIALLY EQUIVALENT 1
REAL TONE TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROSSMAX INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 14
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 2
SCHILLER
  SUBSTANTIALLY EQUIVALENT 2
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
SUNTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
TIBA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TUNG FU ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TYTAN MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 12
XPEREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
YA HORNG ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 12
High Readings 8
Low readings 6
Incorrect measurement 6
Incorrect or inadequate result 5
Device displays error message 4
Application interface becomes non-functional or program exits abnormally 3
Fire 2
Device operates differently than expected 2
Not audible alarm 2
Unintended collision 1
Electronic property issue 1
Flare or flash 1
No Known Device Problem 1
Operating system becomes non-functional 1
No code available 1
Excess flow or overinfusion 1
Sensor problems 1
Device inoperable 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 61

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 2 1 2 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II Nov-29-2011
2 Edwards Lifesciences, LLC II Jun-09-2015
3 FMS, Finapres Medical Systems BV II Aug-06-2012
4 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-15-2010
5 Philips Healthcare Inc. II Feb-14-2013
6 Philips Healthcare Inc. II Aug-30-2012
7 Physio Control, Inc. II Sep-18-2009
8 Smiths Medical PM, Inc. II Aug-25-2008
9 Zoe Medical Incorporated II Aug-03-2010

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