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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, steam
Regulation Description Steam sterilizer.
Product CodeFLE
Regulation Number 880.6880
Device Class 2


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BELIMED
  SUBSTANTIALLY EQUIVALENT 3
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
GETINGE
  SUBSTANTIALLY EQUIVALENT 11
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KAVO
  SUBSTANTIALLY EQUIVALENT 1
MEDILINE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDIN CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 7
MILTON E PEDRAZZI D.D.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS STERILIZER CO., INC.
  SUBSTANTIALLY EQUIVALENT 4
SAUTER AG
  SUBSTANTIALLY EQUIVALENT 5
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
  1.  K000077  STERIS AMSCO MILLENNIUM STEAM STERILIZER
  2.  K010865  AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
  3.  K020747  AMSCO CENTURY MEDIUM STERILIZER 26 X 26
  4.  K030789  AMSCO CENTURY STEAM STERILIZER
  5.  K082435  AMSCO EVOLUTION MEDIUM STEAM STERILIZER
  6.  K091136  AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC- ...
  7.  K091731  AMSCO EVOLUTION MEDIUM STEAM STERILIZER
  8.  K092490  AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC ...
  9.  K111223  AMSCO CHIMERON SMALL STEAM STERILIZER
  10.  K112055  AMSCO CHIMERON MEDIUM STEAM STERILIZER
  11.  K112403  AMSCO CHIMERON MEDIUM STEAM STERLILZER
  12.  K980014  THE SYSTEM 2S STEAM STERILIZER
  13.  K982332  STERIS TEN SIXTEEN STEAM STERILIZER
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER CO. LTD.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Other (for use when an appropriate device code cannot be identified) 6
Improper or incorrect procedure or method 5
Device operates differently than expected 4
Failure to Adhere or Bond 4
Loose 4
Use of Device Issue 3
Normal 2
Misapplication 2
Detachment of device component 2
Component falling 2
Dislodged or dislocated 2
Tipover 2
Unstable 2
Device Issue 2
Malfunction 1
Unknown (for use when the device problem is not known) 1
Valve(s), defective 1
Component missing 1
Locking mechanism failure 1
Environmental Particulates 1
No Information 1
Dislodged 1
Electrical issue 1
Fluid leak 1
Leak 1
Break 1
Device Cleaning Issue 1
Air leak 1
Device alarm system issue 1
Misassembled 1
Mechanical issue 1
Slippage of device or device component 1
Failure to sterilize 1
Water softener process, failure of 1
Total Device Problems 62

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

Recalls
Manufacturer Recall Class Date Posted
1 Midmark Corportation II Jan-11-2012
2 Steris Corp II Sep-17-2008
3 Steris Corp II Aug-23-2007
4 Steris Corporation III Nov-04-2015
5 Steris Corporation II Apr-30-2015
6 Steris Corporation II Dec-11-2013
7 Steris Corporation II Mar-06-2013
8 Steris Corporation II May-11-2012

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