# K050591: Modification to Raven Bacterial Spore Strips

- Pathway: 510(k) (Special)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Mar 23, 2005 after 15 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K141244: Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological Indicator Spore Strips (Single Species) (2014), 0 descendants of its own
- K113221: Namsa Biological Indicator Spore Strips (2012), 0 descendants of its own

## 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 Bacterial Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilusATCC #7953 and B. atrophaeusATCC #9372) is intended for use in testing the efficacy of Chemiclave sterilization cycles at 132 0C. A reduced incubation time of 72 hours at 600C +/- 20C has been validated for Chemiclave sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilusspore 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/K050591
Methodology: https://510kreport.com/methodology