# K151971: STERRAD CYCLESURE 24 Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 29, 2015 after 105 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: 6 generations back to K994055 (2002). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324, Advanced Sterilization Products (2012) Summary page 4.

## Most influential descendants
- K170039: STERRAD VELOCITY Biological Indictator and Reader (2017), 3 descendants of its own
- K182404: STERRAD VELOCITY Biological Indicator (2018), 2 descendants of its own
- K192025: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader (2020), 1 descendant of its own
- K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (2024), 0 descendants of its own
- K171287: Sporview VH202 BI (2018), 0 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 has been validated for use in health care facilities: • STERRAD 100S • STERRAD 50 • STERRAD 200 • STERRAD NX® • STERRAD 100NX® (Standard, Flex and Express Cycles) o For STERRAD 100NX DUO Cycle in the United States, the STERRAD CYCLESURE 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

Source page: https://510kreport.com/device/K151971
Methodology: https://510kreport.com/methodology