# K051173: Spsmedical Sporview Plus Steam BI Test Pack

- Pathway: 510(k) (Special)
- Applicant: Spsmedical Supply Corp.
- Decided: May 27, 2005 after 21 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 K001444 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022706: Spsmedical Sporview Steam BI Test Pack, Spsmedical Supply Corp. (2002) Summary page 1.

## Most influential descendants
- K140620: Sporview Plus BI Test Pack (2014), 0 descendants of its own

## Indications for use
The SPSmedical SporView®Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

Source page: https://510kreport.com/device/K051173
Methodology: https://510kreport.com/methodology
