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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nebulizer, medicinal, non-ventilatory (atomizer)
Regulation Description Medicinal nonventilatory nebulizer (atomizer).
Product CodeCCQ
Regulation Number 868.5640
Device Class 1


Premarket Reviews
ManufacturerDecision
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL PHYSIOTHERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 104
Device operates differently than expected 63
Loss of or failure to bond 58
Failure to fire 53
Leak 47
Break 30
No flow 24
Detachment of device or device component 20
Device damaged prior to use 12
Packaging issue 10
Tear, rip or hole in device packaging 9
Restricted flowrate 8
Device clogged 6
Connection issue 6
Failure to deliver 4
Inaccurate delivery 4
Inadequate instructions for non-healthcare professional 4
Blockage within device or device component 3
Disconnection 3
Unsealed device packaging 3
Component missing 2
No Information 2
Device handling issue 2
Moisture or humidity problem 1
Positioning Issue 1
Device Difficult to maintain 1
Deployment issue 1
Battery issue 1
Occlusion within device 1
Inappropriate shock 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
Kinked 1
Air leak 1
Failure to convert to back-up 1
Total Device Problems 489

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

Recalls
Manufacturer Recall Class Date Posted
1 Nephron Pharmaceuticals Corp. I May-29-2013
2 Salter Laboratories, Division of Regulatory Affairs II Oct-26-2011
3 Teleflex Medical II Nov-09-2016

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