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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
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 14
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 7
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
Adverse Event Without Identified Device or Use Problem 4 4
Use of Device Problem 4 4
Contamination /Decontamination Problem 2 2
Insufficient Information 2 2
Device Reprocessing Problem 1 1
Chemical Problem 1 1
Problem with Sterilization 1 1
Component Missing 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Break 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
Burn(s) 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
Eye Injury 1 1
Skin Discoloration 1 1
Eye Pain 1 1
Laceration(s) 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-26-2023
2 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
3 Steris Corporation II Jan-03-2023
4 TERRAGENE S.A. II Jan-26-2024
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