# K122024: Spsmedical Sporview 10 Steam Self Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Nov 26, 2013 after 503 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: 4 generations back to K801109 (1980). 6 ancestors in all.
1 later device descends 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.
- K111515: Spsmedical Sporview Steam BI, Spsmedical Supply Corp. (2012) Summary page 1.

## Most influential descendants
- K200970: Self-Contained Biological Indicator (2020), 0 descendants of its own

## Indications for use
SparView® 1O Steam is a self-contained biological indicator inoculated with viable Geobacilitis stearorhermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SparView® 10 self-contained biological indicators have a validated reduced incubation time of 1o hours and may be used in the following steam sterilization cycles: Sterilization Mode Temperature Time Gravity 121 0C 30 minutes Gravity 1320C 15 minutes Gravity 134 0C 4 minutes Gravity - Flash 132 0C 3 minutes Gravity - Flash 132 0C 10 minutes Dynamic Air 121 0C 20 minutes Dynamic Air 121 0C 30 minutes Dynamic Air 132 0C 3minutes Dynamic Air 132 0C 4 minutes Dynamic Air 134 0C 4 minutes Dynamic Air 135 0C 3 minutes

Source page: https://510kreport.com/device/K122024
Methodology: https://510kreport.com/methodology