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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device airway, oropharyngeal, anesthesiology
Regulation Description Oropharyngeal airway.
Product CodeCAE
Regulation Number 868.5110
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
LARYNGEAL MASK
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
O-TWO SYSTEMS INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 14
Crack 5
Break 4
Inflation issue 4
Misassembled 4
Occlusion within device 3
Hole in material 3
Detachment of device component 3
Material integrity issue 3
Connection issue 2
Device abrasion from instrument or another object 2
Material rupture 2
Use of Device Issue 2
Improper or incorrect procedure or method 1
Defective item 1
Sticking 1
Difficult to remove 1
Material rigid or stiff 1
Difficult to insert 1
Leak 1
Deflation issue 1
Material fragmentation 1
Positioning Issue 1
Torn material 1
Total Device Problems 62

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 1 0 3 1 1 1 2 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 King Systems Corp. II Jan-10-2014
2 King Systems Corp. II Oct-01-2013
3 King Systems Corp. III Sep-19-2013
4 King Systems Corp. II Nov-21-2012
5 King Systems Corp. II Apr-04-2011
6 King Systems Corp. II Mar-17-2011
7 King Systems Corp. II Jan-27-2011
8 Microtek Medical Inc II Jun-26-2015
9 Sterilmed Inc II Jan-13-2009
10 Teleflex Medical II Feb-10-2015

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