• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device condenser, heat and moisture (artificial nose)
Regulation Description Heat and moisture condenser (artificial nose).
Product CodeBYD
Regulation Number 868.5375
Device Class 1


Premarket Reviews
ManufacturerDecision
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOR
  SUBSTANTIALLY EQUIVALENT 9
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Restricted flowrate 6
Leak 4
Detachment of device component 2
Moisture or humidity problem 2
Blockage within device or device component 1
Disconnection 1
Material fragmentation 1
Loose or intermittent connection 1
Occlusion within device 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Obstruction within device 1
Split 1
Device operates differently than expected 1
Total Device Problems 24

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

Recalls
Manufacturer Recall Class Date Posted
1 Arc Medical Inc III May-09-2015
2 Teleflex Medical I Feb-06-2015
3 Teleflex, Inc. I Feb-06-2015
4 Vital Signs Devices, a GE Healthcare Company I Jul-30-2011

-
-