# K070595: Sporview Steam Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: May 24, 2007 after 83 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: 2 generations back to K801109 (1980). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963841: Eztest, Sgm Biotech, Inc. (1997) Summary page 1.

## Most influential descendants
- K111515: Spsmedical Sporview Steam BI (2012), 2 descendants of its own
- K122024: Spsmedical Sporview 10 Steam Self Contained Biological Indicator (2013), 1 descendant of its own
- K200970: Self-Contained Biological Indicator (2020), 0 descendants of its own

## Indications for use
SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilusbacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121'C and 132'C gravity displacement, 132'C flash gravity displacement and 121 'C - 134'C prevacuum cycles.

Source page: https://510kreport.com/device/K070595
Methodology: https://510kreport.com/methodology