• 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 pump, breast, powered
Regulation Description Powered breast pump.
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
FIRST YEARS
  SUBSTANTIALLY EQUIVALENT 4
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
HEALTHTEAM
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MED-EL
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 9
PLAYTEX PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCHUCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Suction issue 76
Fluid leak 73
Decrease in suction 21
Device operates differently than expected 17
Smoking 15
Inappropriate shock 8
Break 6
No Information 6
Power source issue 4
No Known Device Problem 3
Protective measure issue 2
No code available 2
Battery issue 2
Fire 2
Melted 2
Increase in suction 2
Spark 2
Patient-device incompatibility 1
Obstruction within device 1
Device inoperable 1
Size incorrect for patient 1
Overheating of device or device component 1
Failure to charge 1
Device clogged 1
Crack 1
Application interface becomes non-functional or program exits abnormally 1
Detachment of device or device component 1
Material integrity issue 1
Device handling issue 1
Noise, Audible 1
Total Device Problems 256

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

Recalls
Manufacturer Recall Class Date Posted
1 Energizer Personal Care II Apr-04-2014
2 Medela Inc III Feb-11-2011
3 Medela Inc II Sep-24-2010
4 Medela Inc II Apr-27-2010

-
-