# K041386: Raven Protest - Steam

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Aug 9, 2004 after 76 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.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963841: Eztest, Sgm Biotech, Inc. (1997) Summary page 1.

## Most influential descendants
- K082756: Raven Protest -  Steam Biological Indicator (2009), 1 descendant of its own
- K112018: Smart Read Eztest Steam (2012), 0 descendants of its own

## Indications for use
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.

Source page: https://510kreport.com/device/K041386
Methodology: https://510kreport.com/methodology