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 COMPANY
	SUBSTANTIALLY EQUIVALENT	9
1.  K004009  3M ATTEST 290 AUTO-READER
2.  K031012  ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, ...
3.  K052128  3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-REA ...
4.  K090569  MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL I ...
5.  K101910  3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DE ...
6.  K121484  3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDIC ...
7.  K121593  3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE ...
8.  K123546  3M ATTEST(TM) AUTO-READER
9.  K900771  ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS
	SUBSTANTIALLY EQUIVALENT	15
ALBERT BROWNE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DANA PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
GETINGE
	SUBSTANTIALLY EQUIVALENT	3
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
PROPPER MFG
	SUBSTANTIALLY EQUIVALENT	4
RAVEN
	SUBSTANTIALLY EQUIVALENT	12
SPS
	SUBSTANTIALLY EQUIVALENT	8
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
STERITEC, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Other (for use when an appropriate device code cannot be identified)	172
No code available	55
Use of Device Issue	24
Chemical issue	8
Device disinfection or sterilization issue	5
Device Issue	4
Leak	3
Incorrect or inadequate result	2
Improper or incorrect procedure or method	2
Defective item	2
Wrinkled	1
Component(s), broken	1
Total Device Problems	279

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	0	0	3	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Sterilization Products	II	Dec-12-2012
2	Advanced Sterilization Products	II	Jul-27-2012
3	Advanced Sterilization Products	II	Jun-06-2012
4	Advanced Sterilization Products	II	Oct-20-2009