# K122044: Sterrad (R) Cyclesure (R) 24 Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: Advanced Sterilization Products
- Decided: Oct 4, 2012 after 84 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: 4 generations back to K994055 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103222: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2011) Summary page 1.

## 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/K122044
Methodology: https://510kreport.com/methodology