• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, hemodialysis, access recirculation monitoring
Regulation Description Hemodialysis system and accessories.
Product CodeMQS
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Vibration 16
Unstable 10
Water softener process, failure of 6
Inaccurate flowrate 5
Normal 4
Unknown (for use when the device problem is not known) 3
Injector system failure, overinfusion of 2
Error or warning message, failure to produce 2
Delayed alarm 2
Accuracy rate 2
Restricted flowrate 1
Increased pump speed 1
Total Device Problems 54

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 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Transonic Systems Inc II Mar-18-2015

-
-