# K181434: SporView Rapid Read Biological Indicator SteamPlus Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex/Spsmedical, A Division of Cantel Medical
- Decided: Nov 14, 2018 after 166 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 K925496 (1994). 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)
- K101910: 3M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid Readout Steam-Plus, 3M Company (2010) Summary page 5.

## Indications for use
The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

Source page: https://510kreport.com/device/K181434
Methodology: https://510kreport.com/methodology