# K020026: Raven Bacterial Spore Strips

- Pathway: 510(k) (Special)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Jan 30, 2002 after 26 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
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. The FDA summary names its predicate without a number.
- (no number) Raven Bacterial Spore Strip: named in the summary without a submission number

## 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

## Indications for use
The Raven Bacterial Spare Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at §5-60°C has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. 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/K020026
Methodology: https://510kreport.com/methodology