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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubes, vials, systems, serum separators, blood collection
Regulation Description Blood specimen collection device.
Product CodeJKA
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  1
  SUBSTANTIALLY EQUIVALENT 19
BMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE
  SUBSTANTIALLY EQUIVALENT 6
HOME ACCESS
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 9
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 5
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Air leak 35
Detachment of device component 27
Needle, unsheathed 12
Component(s), broken 11
Break 8
Retraction problem 6
Device operates differently than expected 5
No Known Device Problem 5
Disengaged 5
Leak 4
Needle, separation 4
Improper or incorrect procedure or method 4
Shielding failure 3
Use of Device Issue 3
Fluid leak 3
Fracture 3
Failure to capture 2
Detachment of device or device component 2
Unknown (for use when the device problem is not known) 2
Incorrect or inadequate test results 1
Defective item 1
Slippage of device or device component 1
Spillage, accidental 1
Sticking 1
Inadequate training 1
Protective measure issue 1
Dislodged or dislocated 1
Improper flow or infusion 1
Contamination during use 1
Material fragmentation 1
Hole in material 1
Misapplication 1
Fail-safe design failure 1
User used incorrect product for intended use 1
Difficult to remove 1
Incorrect or inadequate result 1
Total Device Problems 161

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