Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
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 abrasion from instrument or another object 2
Difficult to remove 1
Use of Device Issue 1
Connection issue 1
Break 1
Crack 1
Deflation issue 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 3 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 King Systems Corp. II Nov-21-2012
2 King Systems Corp. II Apr-04-2011
3 King Systems Corp. II Mar-17-2011
4 King Systems Corp. II Jan-27-2011
5 Sterilmed Inc II Jan-13-2009

-
-