# K133204: Airview Mini Owie Dick Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International
- Decided: May 5, 2014 after 200 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K841168 (1984). 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)
- K130211: Airview Bowie Dick; Test Pack, Indicator Sheets, Spsmedical Supply Corp. (2013) Summary page 1.

## Indications for use
The AirView II Bowie Dick Test Pack is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 134°C for 3.5 minutes. The indicator sheet within the AirView II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown/black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1°/-0°C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView II Bowie Dick Test Pack will demonstrate a non-uniform color change.

Source page: https://510kreport.com/device/K133204
Methodology: https://510kreport.com/methodology