# K071014: Modification to Sterrad Cyclesure Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: Advanced Sterilization Products
- Decided: May 24, 2007 after 44 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994055 (2002). 2 ancestors in all.
42 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031226: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2003) Summary page 1.
- K994055: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2002) Summary page 1.

## Most influential descendants
- K103222: Sterrad Cyclesure Biological Indicator (2011), 20 descendants of its own
- K102884: Sterrad Cyclesure 24 Biological Indicator (2011), 20 descendants of its own
- K073244: Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes (2008), 20 descendants of its own
- K111375: Sterrad (R) Cyclesure (R) 24 Biological Indicator (2012), 18 descendants of its own
- K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324 (2012), 17 descendants of its own

## Indications for use
The STERRAD® CycleSure® Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles

Source page: https://510kreport.com/device/K071014
Methodology: https://510kreport.com/methodology