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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 4

Device Problems
Air leak 311
Leak 63
Fracture 44
Break 28
Detachment of device component 28
Deflation, cause unknown 20
Crack 18
Component(s), broken 10
Inflation issue 10
No Known Device Problem 10
Replace 7
Locking mechanism failure 7
Connection issue 7
Device, removal of (non-implant) 6
Decrease in pressure 6
Fitting problem 6
Hole in material 6
Kinked 5
Deflation issue 5
Tears, rips, holes in device, device material 5
Unknown (for use when the device problem is not known) 5
Unintended movement 5
Device operates differently than expected 4
Use of Device Issue 4
Material rupture 4
Balloon leak(s) 4
Balloon asymmetrical 3
Burst 3
Fluid leak 3
Disconnection 3
Occlusion within device 3
Material separation 3
Safety interlock(s) inadequate 3
Sticking 3
Dislodged or dislocated 3
Torn material 3
Pressure issue 2
Difficult to advance 2
No code available 2
Component or accessory incompatibility 2
Detachment of device or device component 2
Sharp/jagged/rough/etched/scratched 2
Device damaged prior to use 2
Obstruction within device 2
Failure to disconnect 2
Suction issue 2
Improper or incorrect procedure or method 2
Tip breakage 2
Difficult to remove 2
Slippage of device or device component 2
Occlusion, incorrect 2
Loose or intermittent connection 2
Material fragmentation 2
Difficult to insert 2
Bent 2
Blockage within device or device component 2
Device alarm system issue 2
Balloon rupture 1
Entrapment of device or device component 1
Restricted flowrate 1
Design/structure problem 1
Component incompatible 1
Installation error 1
Intraprocedure, fire or flash during 1
Device maintenance issue 1
Melted 1
Peeled 1
Premature deployment 1
Material puncture 1
Reaction 1
Size incorrect for patient 1
Uncoiled 1
Other (for use when an appropriate device code cannot be identified) 1
Physical resistance 1
Cut in material 1
Structural problem 1
Device Issue 1
Material perforation 1
Malposition of device 1
Patient-device incompatibility 1
Device misassembled during manufacturing or shipping 1
Naturally worn 1
Positioning Issue 1
Total Device Problems 726

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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