# K111375: Sterrad (R) Cyclesure (R) 24 Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Sep 14, 2012 after 487 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). 5 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K102884: Sterrad Cyclesure 24 Biological Indicator, Advanced Sterilization Products (2011) Summary page 1.
- K103222: Sterrad Cyclesure Biological Indicator, Advanced Sterilization Products (2011) Summary page 1.

## Most influential descendants
- 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
- K171003: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (2017), 5 descendants of its own

## 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: * STERRAD® 1005S * STERRAD® 50 * STERRAD® 200 * STERRAD® NX® * STERRAD® 100NX® (Standard, Flex and Express Cycles) o For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

Source page: https://510kreport.com/device/K111375
Methodology: https://510kreport.com/methodology