# K172432: SporView Rapid Read Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex/Spsmedical, A Division of Cantel Medical
- Decided: Dec 12, 2017 after 123 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 K926364 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292, 3M Company (2009) Summary page 4.
- K926364: Attest Brand Rapid Readout Biological Ind. #129X, 3M Health Care, Ltd. (1995) Summary page 4.

## Indications for use
The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.

Source page: https://510kreport.com/device/K172432
Methodology: https://510kreport.com/methodology