• 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 set, tubing, blood, with and without anti-regurgitation valve
Regulation Description Hemodialysis system and accessories.
Product CodeFJK
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 4
GAMBRO
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 124
Fluid leak 106
Material separation 100
Kinked 95
No Information 38
Leak 33
Unknown (for use when the device problem is not known) 32
Disconnection 31
Hole in material 15
Detachment of device component 14
Air leak 12
Normal 12
Not Applicable 11
Other (for use when an appropriate device code cannot be identified) 10
Defective component 9
No code available 9
Device operates differently than expected 8
Cut in material 8
Loose or intermittent connection 8
Misconnection 7
Use of Device Issue 7
Connection issue 6
Overdelivery 6
Method, improper/incorrect 6
Loss of or failure to bond 5
Crack 5
Device alarm system issue 4
Occlusion within device 4
Source, detachment from 3
Failure to Adhere or Bond 3
Coagulation in device or device ingredient 3
Tip breakage 3
Material rupture 2
Device damaged prior to use 2
Break 2
Defective Alarm 2
Decoupling 2
Decrease in pressure 2
Increase in pressure 2
Migration of device or device component 2
Device maintenance issue 2
Mechanical issue 2
Fracture 1
Reaction 1
Alarm system, failure of check-catheter 1
Connector pin failure 1
Couple, failure to 1
Dislocated 1
Emergency stop button or switch failure 1
Filter 1
Restricted flowrate 1
Blockage within device or device component 1
Component(s), broken 1
Tube(s), shattering of 1
Unit inactivated 1
Improper or incorrect procedure or method 1
Suction issue 1
Device Issue 1
Tube(s), defective 1
Detachment of device or device component 1
Split 1
Patient-device incompatibility 1
Filtration issue 1
Foreign material present in device 1
Improper flow or infusion 1
Infusion or flow issue 1
Total Device Problems 781

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

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. III May-07-2008
2 Fresenius Medical Care Holdings, Inc. I Jan-10-2011
3 Gambro Renal Products, Inc. II Sep-26-2008
4 Gambro Renal Products, Incorporated II Apr-11-2014
5 Nipro Medical Corporation II Jan-08-2016

-
-