# K140620: Sporview Plus BI Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International
- Decided: Aug 7, 2014 after 149 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 K001444 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051173: Spsmedical Sporview Plus Steam BI Test Pack, Spsmedical Supply Corp. (2005) Summary page 4.

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

Source page: https://510kreport.com/device/K140620
Methodology: https://510kreport.com/methodology