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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, respiratory gas, (direct patient interface)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN BANTEX CORP
  SUBSTANTIALLY EQUIVALENT 1
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 14
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 5
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISIZE BV
  SUBSTANTIALLY EQUIVALENT 3
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
PACIFIC MEDICO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED
  SUBSTANTIALLY EQUIVALENT 2
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 6
VAPOTHERM
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Not audible alarm 820
Power source issue 224
Failure to power-up 182
Connection issue 173
Device operates differently than expected 143
Leak 138
Temperature issue 122
Crack 110
Device alarm system issue 93
Insufficient heating 90
Overheating of device or device component 58
Device Issue 46
Detachment of device component 40
Other (for use when an appropriate device code cannot be identified) 33
Melted 28
Break 24
Burn of device or device component 22
Air leak 21
Disconnection 21
Device stops intermittently 20
Component missing 19
Fluid leak 19
Fitting problem 18
Device handling issue 17
No flow 17
Device sensing issue 16
No display or display failure 15
Circuit Failure 14
Tear, rip or hole in device packaging 14
Overfill 14
Moisture or humidity problem 13
Hole in material 13
Protective measure issue 11
Device displays error message 11
Failure of device to self-test 11
No Known Device Problem 10
No code available 10
Corrosion 10
Kinked 10
Device emits odor 10
No Information 9
Defective item 9
Material separation 9
Failure to deliver 8
Pressure issue 8
Restricted flowrate 8
False alarm 8
Bent 8
Loss of or failure to bond 7
Detachment of device or device component 7
Failure to sense 7
Use of Device Issue 7
Split 5
Cut in material 5
Blockage within device or device component 5
Artifact 5
Mechanical issue 5
Occlusion within device 4
Heat 4
Loose or intermittent connection 4
Burst 4
Defective Alarm 4
Threader failure 4
Material deformation 3
Difficult to open or close 3
Torn material 3
Noise, Audible 3
Alarm not visible 3
Component(s), broken 3
Material discolored 3
Fire 3
Filling problem 3
Moisture damage 3
Delivered as unsterile product 2
Migration of device or device component 2
Loss of power 2
Output, low 2
No device output 2
Filter 2
Incorrect display 2
Component(s), overheating of 2
Connection error 2
Improper flow or infusion 2
Device Contamination with biological material 2
Stretched 2
Improper or incorrect procedure or method 2
Smoking 2
Sterility 2
Failure to align 2
Malfunction 2
Incomplete or missing packaging 2
Device damaged prior to use 2
Temperature probe, loose 1
Valve(s), defective 1
Tube(s), defective 1
Burn hole(s) 1
Inaccurate delivery 1
Obstruction within device 1
Failure to advance 1
Sticking 1
Total Device Problems 2900

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 0 0
Class II 2 1 0 1 1 1 0 3 3 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare Inc II Dec-10-2008
2 Porous Media Corporation II Jun-20-2007
3 Respironics, Inc. II Jan-10-2007
4 Telefelx Medical II Mar-09-2010
5 Teleflex Medical II Dec-15-2015
6 Teleflex Medical II Apr-30-2015
7 Teleflex Medical II Feb-12-2015
8 Teleflex Medical II Jul-23-2014
9 Teleflex Medical II Jul-07-2014
10 Teleflex Medical II Jul-19-2012
11 Teleflex Medical II Jul-12-2011
12 Teleflex Medical I Aug-13-2010
13 Vapotherm, Inc. II Sep-25-2014

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