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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheostomy (w/wo connector)
Regulation Description Tracheostomy tube and tube cuff.
Product CodeBTO
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ERIE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 6
POSEY
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 13
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Air leak 304
Leak 49
Fracture 44
Detachment of device component 24
Deflation, cause unknown 20
Break 18
Crack 15
Component(s), broken 10
No Known Device Problem 8
Locking mechanism failure 7
Replace 7
Fitting problem 6
Device, removal of (non-implant) 6
Connection issue 6
Inflation issue 6
Unknown (for use when the device problem is not known) 5
Tears, rips, holes in device, device material 5
Unintended movement 5
Hole in material 4
Kinked 4
Balloon leak(s) 4
Deflation issue 4
Fluid leak 3
Disconnection 3
Balloon asymmetrical 3
Burst 3
Occlusion within device 3
Use of Device Issue 3
Safety interlock(s) inadequate 3
Material separation 3
Sticking 3
Device operates differently than expected 3
Device damaged prior to use 2
Sharp/jagged/rough/etched/scratched 2
Slippage of device or device component 2
Decrease in pressure 2
Suction issue 2
Improper or incorrect procedure or method 2
Tip breakage 2
Occlusion, incorrect 2
Loose or intermittent connection 2
Material fragmentation 2
Bent 2
Blockage within device or device component 2
Failure to disconnect 2
Pressure issue 2
Torn material 2
Balloon rupture 1
Entrapment of device or device component 1
Restricted flowrate 1
Design/structure problem 1
Component incompatible 1
Difficult to insert 1
Installation error 1
Intraprocedure, fire or flash during 1
Device maintenance issue 1
Melted 1
Peeled 1
Premature deployment 1
Uncoiled 1
Other (for use when an appropriate device code cannot be identified) 1
Material puncture 1
Reaction 1
Difficult to remove 1
Size incorrect for patient 1
Component or accessory incompatibility 1
Device Issue 1
Cut in material 1
Material perforation 1
Difficult to advance 1
Dislodged or dislocated 1
Naturally worn 1
Detachment of device or device component 1
Device misassembled during manufacturing or shipping 1
Positioning Issue 1
Total Device Problems 649

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 1 1 0 0 0
Class II 0 0 2 0 2 1 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Mar-24-2016
2 Arcadia Medical Corporation II May-21-2012
3 Arcadia Medical Corporation II Jun-24-2011
4 Bryan Medical Inc I Jul-08-2013
5 Gf Health Products, Inc. II Nov-09-2009
6 Instrumentation Industries Inc II Nov-12-2015
7 Instrumentation Industries Inc II Sep-03-2009
8 Nellcor Puritan Bennett Inc. (dba Covidien Ltd) I May-06-2010
9 Smiths Medical ASD, Inc. I Jan-19-2012
10 VBM Medical Inc. II Jun-28-2011

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