# K151585: Andersen EOGas 4 SteriTest

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 18, 2015 after 160 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: 2 generations back to K801109 (1980). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930683: Eztest-Gas, Sgm Biomedical, Inc. (1997) Summary page 5.

## Most influential descendants
- K202879: EOGas 4 Endo-SteriTest RRBI (2021), 0 descendants of its own
- K192980: EOGas 4 Endo-SteriTest (2020), 0 descendants of its own
- K170427: Anprolene SteriTest (2017), 0 descendants of its own

## Indications for use
The Andersen EOGas 4 SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized below in Table 1. Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g ± 5% 50°C ± 3°C 35-90% 3 hours 3.5 hours

Source page: https://510kreport.com/device/K151585
Methodology: https://510kreport.com/methodology