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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, bacterial, breathing-circuit
Regulation Description Breathing circuit bacterial filter.
Product CodeCAH
Regulation Number 868.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 5
DHD HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EMERGENCY FILTRATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 4
MEDISIZE BV
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Blockage within device or device component 30
Leak 25
Device operates differently than expected 18
Tear, rip or hole in device packaging 16
Material discolored 16
Occlusion within device 15
Restricted flowrate 12
Detachment of device component 11
Detachment of device or device component 11
No Known Device Problem 8
Crack 8
Material separation 8
Break 7
Air leak 6
Failure to infuse 5
Increase in pressure 4
Product quality issue 3
Disconnection 3
Device inoperable 3
Dislodged or dislocated 2
Foreign material present in device 2
Filter 2
Device clogged 2
Loose 2
Sediment, precipitate or deposit in device or device ingredient 2
Ventilation issue in device environment 1
No Information 1
Packaging issue 1
Moisture damage 1
Inflation issue 1
Particulates 1
Port leak(s) 1
Disassembly 1
Filter break(s) 1
Filter, assembly 1
Infusion or flow issue 1
Installation-related problem 1
Item contaminated during manufacturing or shipping 1
Filtration issue 1
Component missing 1
Tidal volume fluctuations 1
Malfunction 1
Split 1
Connection issue 1
Total Device Problems 240

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

Recalls
Manufacturer Recall Class Date Posted
1 A M Systems Inc II Jan-11-2012
2 Continental Medical Labs,Inc II Jun-03-2010
3 Pall Corporation II Jul-10-2014
4 Vital Signs Colorado Inc. II Jan-23-2014

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