# K171287: Sporview VH202 BI

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp. A Division of Cantel Medical
- Decided: Feb 1, 2018 after 276 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: 7 generations back to K994055 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151971: STERRAD CYCLESURE 24 Biological Indicator, Advanced Sterilization Products (2015) Summary page 4.

## Indications for use
The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system: • STERRAD® 100NX® (Standard Cycle)

Source page: https://510kreport.com/device/K171287
Methodology: https://510kreport.com/methodology