TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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	2
STERIS
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
TERRAGENE
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE S.A.
	SUBSTANTIALLY EQUIVALENT	3
TRUE INDICATING, LLC
	SUBSTANTIALLY EQUIVALENT	1
TSO3 INC., NOW A PART OF STRYKER
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	16	20
2021	10	10
2022	9	9
2023	20	20
2024	22	22
2025	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	54	54
Leak/Splash	6	6
Insufficient Information	4	4
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Break	3	3
Contamination /Decontamination Problem	2	6
Component Missing	2	2
Chemical Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	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	51	51
No Consequences Or Impact To Patient	14	14
Insufficient Information	6	6
No Known Impact Or Consequence To Patient	3	7
Burn(s)	3	3
Laceration(s)	2	2
Skin Discoloration	1	1
Discomfort	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