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 heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description Breathing system heater.
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Air leak 5
Leak 4
Device operates differently than expected 4
Other (for use when an appropriate device code cannot be identified) 3
Not audible alarm 2
Bent 2
Detachment of device component 2
Shock, electrical 1
Fluid leak 1
Heat, failure to 1
Break 1
Burn of device or device component 1
Artifact 1
Failure to advance 1
No code available 1
Overheating of device or device component 1
Use of Device Issue 1
Fitting problem 1
Total Device Problems 33

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

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc I Jun-29-2012

-
-