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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
Power source issue 183
Connection issue 166
Failure to power-up 152
Leak 109
Temperature issue 78
Device operates differently than expected 69
Not audible alarm 69
Insufficient heating 67
Device alarm system issue 47
Crack 41
Detachment of device component 40
Overheating of device or device component 40
Other (for use when an appropriate device code cannot be identified) 33
Break 23
Burn of device or device component 20
Melted 20
Component missing 19
Device Issue 19
Device stops intermittently 18
Disconnection 17
Air leak 16
Circuit Failure 14
Fluid leak 14
Tear, rip or hole in device packaging 14
Fitting problem 14
Overfill 12
No flow 12
No display or display failure 12
Corrosion 10
Kinked 10
Moisture or humidity problem 10
Protective measure issue 10
No code available 10
Device displays error message 10
Material separation 9
No Known Device Problem 9
Defective item 9
Failure of device to self-test 8
Device emits odor 8
Bent 8
Loss of or failure to bond 7
Restricted flowrate 7
No Information 7
Detachment of device or device component 7
Device handling issue 6
Device sensing issue 6
Hole in material 6
Blockage within device or device component 5
Artifact 5
Split 5
Threader failure 4
Use of Device Issue 4
Pressure issue 4
Heat 4
Mechanical issue 4
Occlusion within device 4
Failure to sense 4
Moisture damage 3
Fire 3
Alarm not visible 3
Defective Alarm 3
Component(s), broken 3
Cut in material 3
Failure to align 2
Stretched 2
Malfunction 2
Device Contamination with biological material 2
Improper or incorrect procedure or method 2
Smoking 2
Sterility 2
Incomplete or missing packaging 2
Failure to deliver 2
Torn material 2
Material deformation 2
Improper flow or infusion 2
Noise, Audible 2
Component(s), overheating of 2
Connection error 2
Incorrect display 2
Filling problem 2
Filter 2
Burst 2
Delivered as unsterile product 2
Migration of device or device component 2
Output, low 2
Loss of power 2
Particulates 1
Port leak(s) 1
Sensor problems 1
Decrease in pressure 1
Increase in pressure 1
Misassembled 1
Material opacification 1
Output energy incorrect 1
Method, improper/incorrect 1
Loose or intermittent connection 1
Loose 1
Instruction for use issue 1
Interference with monitoring device 1
Material fragmentation 1
Total Device Problems 1616

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