# K192980: EOGas 4 Endo-SteriTest

- Pathway: 510(k) (Traditional)
- Applicant: Andersen Sterilizers, Inc.
- Decided: Nov 12, 2020 after 385 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: 3 generations back to K801109 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151585: Andersen EOGas 4 SteriTest, Andersen Sterilizers, Inc. (2015) Summary page 5.

## Indications for use
The EOGas 4 Endo-SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer Ethylene Oxide Temperature Relative Humidity EO Exposure Time Total Cycle Time 17.6 g ± 5% 50°C ± 3°C 35-90% 6 hours 7 hours

Source page: https://510kreport.com/device/K192980
Methodology: https://510kreport.com/methodology