TPLC - Total Product Life Cycle

• Device: system, measurement, blood-pressure, non-invasive
• Regulation Description: Noninvasive blood pressure measurement system.
• Product Code: DXN
• Regulation Number: 870.1130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	41
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	1
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	38
HEALTH HERO NETWORK, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEALTHSTATS INTERNATIONAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	4
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	3
IDEAL LIFE INC.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JAWON MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
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	21
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	22
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	3
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	2
SUNTECH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
SUZUKEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
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
High Readings	6
Low readings	2
Device displays error message	1
Electronic property issue	1
Flare or flash	1
No code available	1
Fire	1
Incorrect or inadequate result	1
Sensor problems	1
Use of Device Issue	1
Improper or incorrect procedure or method	1
Total Device Problems	17

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

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