• 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 indicator, biological sterilization process
Regulation Description Sterilization process indicator.
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 12
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 17
  1.  K031226  STERRAD CYCLESURE BIOLOGICAL INDICATOR
  2.  K042450  STERRAD NX CHALLENGE PACK
  3.  K051643  STERRAD STERILIZER CYCLESURE TEST PACK
  4.  K071014  MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDIC ...
  5.  K071537  STERRAD 100NX TEST PACK
  6.  K092755  STERRAAD 100NX EXPRESS CYCLE TEST PACK
  7.  K102884  STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
  8.  K103222  STERRAD CYCLESURE BIOLOGICAL INDICATOR
  9.  K111375  STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
  10.  K111391  STERRAD (R) 100NX DUO CYCLE TEST PACK
  11.  K122044  STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
  12.  K123017  STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14 ...
  13.  K130263  STERRAD 50/100S/200 TEST PACK
  14.  K151971  STERRAD CYCLESURE 24 Biological Indicator
  15.  K991675  MODIFICATION OF: STERRAD BI TEST PACK
  16.  K993775  STERRAD BI TEST PACK
  17.  K994055  STERRAD CYCLESURE BIOLOGICAL INDICATOR
ALBERT BROWNE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DANA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GETINGE
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 4
RAVEN
  SUBSTANTIALLY EQUIVALENT 12
SPS
  SUBSTANTIALLY EQUIVALENT 9
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
STERITEC, INC.
  SUBSTANTIALLY EQUIVALENT 3
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 301
Other (for use when an appropriate device code cannot be identified) 172
Chemical issue 112
Use of Device Issue 24
Device disinfection or sterilization issue 5
Device Issue 4
Improper or incorrect procedure or method 3
Leak 3
Incorrect or inadequate result 2
Shelf life exceeded 2
Defective item 2
Device operates differently than expected 2
Environmental Particulates 1
No Information 1
Wrinkled 1
Sterility 1
Material separation 1
Component(s), broken 1
False positive result 1
Material fragmentation 1
Chemical spillage 1
Total Device Problems 641

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 1 0 0 3 6 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-07-2014
2 Advanced Sterilization Products II Dec-28-2013
3 Advanced Sterilization Products II Apr-26-2013
4 Advanced Sterilization Products II Dec-12-2012
5 Advanced Sterilization Products II Jul-27-2012
6 Advanced Sterilization Products II Jun-06-2012
7 Advanced Sterilization Products II Oct-20-2009
8 Getinge USA Inc II Aug-21-2013
9 Mesa Laboratories, Inc., Bozeman Manufacturing Facility II Aug-01-2013
10 Steris Corporation II Dec-28-2013
11 Steritec Products Mfc. Co., Inc. II Jul-29-2013

-
-