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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 352
Power source issue 222
Failure to power-up 178
Connection issue 168
Leak 127
Device operates differently than expected 113
Temperature issue 101
Device alarm system issue 87
Insufficient heating 81
Crack 77
Overheating of device or device component 50
Detachment of device component 40
Other (for use when an appropriate device code cannot be identified) 33
Device Issue 33
Melted 25
Break 24
Burn of device or device component 22
Disconnection 20
Device stops intermittently 20
Component missing 19
Air leak 19
Fitting problem 16
No flow 16
Device sensing issue 16
Tear, rip or hole in device packaging 14
Circuit Failure 14
Fluid leak 14
No display or display failure 13
Overfill 13
Moisture or humidity problem 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 9
Hole in material 9
Device handling issue 9
No Information 9
Defective item 9
Material separation 9
Pressure issue 8
Restricted flowrate 8
Bent 8
False alarm 7
Loss of or failure to bond 7
Detachment of device or device component 7
Failure to sense 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
Threader failure 4
Use of Device Issue 4
Failure to deliver 3
Torn material 3
Fire 3
Moisture damage 3
Burst 3
Defective Alarm 3
Alarm not visible 3
Component(s), broken 3
Component(s), overheating of 2
Connection error 2
Incorrect display 2
Delivered as unsterile product 2
Migration of device or device component 2
Loss of power 2
Output, low 2
No device output 2
Filling problem 2
Filter 2
Noise, Audible 2
Device Contamination with biological material 2
Material deformation 2
Improper flow or infusion 2
Incomplete or missing packaging 2
Device damaged prior to use 2
Failure to align 2
Malfunction 2
Improper or incorrect procedure or method 2
Stretched 2
Smoking 2
Sterility 2
Sticking 1
Slippage of device or device component 1
Sensor problems 1
Decrease in pressure 1
Increase in pressure 1
Tears, rips, holes in device, device material 1
Device inoperable 1
Noise 1
Insufficient flow or underinfusion 1
Obstruction within device 1
Total Device Problems 2242

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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