# K032914: Modification to:Raven Bacterial Spore Strips

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: May 25, 2004 after 246 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Apr 13, 2026 · Class II · Z-2331-2026: Due to incorrect incubation process being performed on product.
- Apr 13, 2026 · Class II · Z-2332-2026: Due to incorrect incubation process being performed on product.

## Indications for use
The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135 C. A reduced incubation time of 24 hours at 60°C ± 2 0C has been validated for steam sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Source page: https://510kreport.com/device/K032914
Methodology: https://510kreport.com/methodology