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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, dialysate delivery, single patient
Regulation Description Hemodialysis system and accessories.
Product CodeFKP
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 5
GAMBRO
  SUBSTANTIALLY EQUIVALENT 6
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 10
Conductivity 9
Output, high 5
Calibration error 3
Device displays error message 3
Disinfection or Sterilization Issue at User Location 2
Failure to disinfect 2
Unknown (for use when the device problem is not known) 2
Device alarm system issue 2
No code available 2
Air leak 1
Alarm, audible 1
No device output 1
Failure to power-up 1
Ultrafiltration 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Material perforation 1
No Known Device Problem 1
Sediment, precipitate or deposit in device or device ingredient 1
Temperature issue 1
Not Applicable 1
Total Device Problems 52

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 0 2 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Renal Div II Apr-12-2010
2 Fresenius Medical Care North America II Aug-15-2010
3 Hach Co II Sep-21-2008

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