# K022706: Spsmedical Sporview Steam BI Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Oct 25, 2002 after 72 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: 1 generation back to K001444 (2000). 1 ancestor in all.
2 later devices descend 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)
- K001444: Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103, Steritec Products, Inc. (2000)

## Most influential descendants
- K051173: Spsmedical Sporview Plus Steam BI Test Pack (2005), 1 descendant of its own
- K140620: Sporview Plus BI Test Pack (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K022706
Methodology: https://510kreport.com/methodology