# K994055: Sterrad Cyclesure Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Feb 13, 2002 after 806 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 5 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M™ Attest™ Biological Indicator: named in the summary without a submission number
- (no number) STERRAD® BI Test Pack: named in the summary without a submission number

## Most influential descendants
- K031226: Sterrad Cyclesure Biological Indicator (2003), 43 descendants of its own
- K071014: Modification to Sterrad Cyclesure Biological Indicator (2007), 42 descendants of its own
- 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

## Recalls of this device
- Jun 23, 2009 · Not classified · Z-0066-2010: Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maxim

## Indications for use
The STERRAD® CycleSureTM 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/K994055
Methodology: https://510kreport.com/methodology