# K041784: Raven Protest - EO

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Sep 13, 2004 after 74 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.
No later device cites it as a predicate yet.
0 of 5 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 1.

## Indications for use
Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.

Source page: https://510kreport.com/device/K041784
Methodology: https://510kreport.com/methodology