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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device circuit, breathing (w connector, adaptor, y piece)
Regulation Description Anesthesia breathing circuit.
Product CodeCAI
Regulation Number 868.5240
Device Class 1


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 9
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Leak 142
Crack 84
Split 34
Air leak 17
Device Issue 14
Device alarm system issue 9
Disconnection 9
Hole in material 9
Degraded 8
Melted 7
Detachment of device component 6
Break 5
Tears, rips, holes in device, device material 5
Tube(s), splitting of 5
No Known Device Problem 5
Malfunction 4
Use of Device Issue 4
Material separation 3
Component(s), broken 3
Cut in material 3
Connection issue 3
Device operates differently than expected 3
No flow 3
Gas leak 2
Material rupture 2
Tear, rip or hole in device packaging 2
Loss of or failure to bond 2
Connection error 2
Loose or intermittent connection 2
Device inoperable 2
Unstable 2
Other (for use when an appropriate device code cannot be identified) 2
Unknown (for use when the device problem is not known) 1
Defective component 1
Burn hole(s) 1
Out-of-box failure 1
Residue after decontamination 1
Failure to deliver 1
Underdelivery 1
Tidal volume fluctuations 1
Smoking 1
Sticking 1
Fracture 1
Method, improper/incorrect 1
Misassembled 1
Normal 1
Occlusion within device 1
Replace 1
Component(s), overheating of 1
Disassembly 1
Obstruction within device 1
Communication or transmission issue 1
Infusion or flow issue 1
No Pressure 1
Protective measure issue 1
Torn material 1
Ventilation issue in device environment 1
Misassembled by Users 1
Total Device Problems 429

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

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Sep-09-2009
2 Impact Instrumentation, Inc. II Jan-12-2012
3 Instrumentation Industries Inc II Dec-29-2013
4 King Systems Corp. I Sep-27-2013
5 King Systems Corp. II Feb-03-2009
6 Teleflex Medical I Sep-30-2014
7 Teleflex Medical II Jul-23-2014

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