# K111515: Spsmedical Sporview Steam BI

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Feb 1, 2012 after 245 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: 3 generations back to K801109 (1980). 5 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K070595: Sporview Steam Self-Contained Biological Indicator, Spsmedical Supply Corp. (2007) Summary page 1.

## Most influential descendants
- 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 stearothermophilus bacterial 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. SporView® self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.

Source page: https://510kreport.com/device/K111515
Methodology: https://510kreport.com/methodology