# K053212: Raven Propact

- Pathway: 510(k) (Special)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Feb 15, 2006 after 91 days
- Product code: MRB (Indicator, Biological, Liquid Chemical 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1TM, a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.

Source page: https://510kreport.com/device/K053212
Methodology: https://510kreport.com/methodology