# K103222: Sterrad Cyclesure Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Feb 25, 2011 after 116 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K994055 (2002). 3 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071014: Modification to Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2007) Summary page 1.

## Most influential descendants
- 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
- K140392: 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader (2014), 12 descendants of its own
- K152060: 3M Attest Rapid Readout Biological Indicator 1295 (2015), 11 descendants of its own
- K160546: 3M Attest Rapid Readout Biological Indicator (2016), 6 descendants of its own

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0604-2014: Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the
- Oct 3, 2012 · Class II · Z-0520-2013: Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data
- Jun 28, 2012 · Class II · Z-2100-2012: Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of t
- Feb 17, 2012 · Not classified · Z-1773-2012: The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used 

## Indications for use
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

Source page: https://510kreport.com/device/K103222
Methodology: https://510kreport.com/methodology