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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device indicator, biological sterilization process
Regulation Description Sterilization process indicator.
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M
  SUBSTANTIALLY EQUIVALENT 1
  1.  K192550  3MTM AttestTM Super Rapid Steam Biological Indicat ...
  2.  K193154  3M Attest Super Rapid 5 Steam-Plus Challenge Pack
  3.  K200766  3M Attest Steam Chemical Integrator Test Pack
  4.  K200996  3M Attest Rapid Readout Biological Indicator
  5.  K210277  3M Attest Rapid Readout Biological Indicator, 1295
  6.  K211705  3M Attest Rapid Readout Biological Indicator, 1295
  7.  K213809  3M Attest Super Rapid Steam Biological Indicator, ...
  8.  K233814  3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxid ...
  9.  K240717  3M™ Attest™ Rapid Readout Biological Indicator 129 ...
  10.  K241542  3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxid ...
  11.  K241710  3M™ Attest™ Super Rapid Readout Biological Indicat ...
  12.  K241959  3M™ Attest™ Super Rapid Steam Clear Challenge Pack ...
  13.  K242538  3M™ Attest™ Super Rapid Readout Biological Indicat ...
  14.  K243501  3M™ Attest™ Super Rapid Steam Extended Cycle Clear ...
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 14
  1.  K192550  3MTM AttestTM Super Rapid Steam Biological Indicat ...
  2.  K193154  3M Attest Super Rapid 5 Steam-Plus Challenge Pack
  3.  K200766  3M Attest Steam Chemical Integrator Test Pack
  4.  K200996  3M Attest Rapid Readout Biological Indicator
  5.  K210277  3M Attest Rapid Readout Biological Indicator, 1295
  6.  K211705  3M Attest Rapid Readout Biological Indicator, 1295
  7.  K213809  3M Attest Super Rapid Steam Biological Indicator, ...
  8.  K233814  3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxid ...
  9.  K240717  3M™ Attest™ Rapid Readout Biological Indicator 129 ...
  10.  K241542  3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxid ...
  11.  K241710  3M™ Attest™ Super Rapid Readout Biological Indicat ...
  12.  K241959  3M™ Attest™ Super Rapid Steam Clear Challenge Pack ...
  13.  K242538  3M™ Attest™ Super Rapid Readout Biological Indicat ...
  14.  K243501  3M™ Attest™ Super Rapid Steam Extended Cycle Clear ...
3M COMPLANY
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS (ASP)
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
TERRAGENE S.A.
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 2
TRUE INDICATING LLC
  SUBSTANTIALLY EQUIVALENT 1
TSO3 INC., NOW A PART OF STRYKER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 10 10
2022 9 9
2023 20 20
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 53 53
Leak/Splash 6 6
Use of Device Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Contamination /Decontamination Problem 2 2
Chemical Problem 1 1
Break 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Missing 1 1
Problem with Sterilization 1 1
No Apparent Adverse Event 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 3 3
Burn(s) 3 3
Insufficient Information 2 2
Skin Discoloration 1 1
Discomfort 1 1
Laceration(s) 1 1
Eye Injury 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-26-2023
2 HF Acquisition Co LLC II Feb-11-2025
3 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
4 Steris Corporation II Jan-03-2023
5 TERRAGENE S.A. II Feb-27-2025
6 TERRAGENE S.A. II Jan-26-2024
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