# K082756: Raven Protest -  Steam Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Oct 21, 2009 after 397 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.
1 later device descends from it; 1 cites 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)
- K041386: Raven Protest - Steam, Raven Biological Laboratories, Inc. (2004) Summary page 1.

## Most influential descendants
- 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 Geobacillus stearothermnophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132 0C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.

Source page: https://510kreport.com/device/K082756
Methodology: https://510kreport.com/methodology