# K041017: Spsmedical Airview Bowie Dick Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Jun 25, 2004 after 66 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: 1 generation back to K841168 (1984). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841168: Sterilization Process Indicator, Parke-Davis Co. (1984) Summary page 1.

## Most influential descendants
- K130211: Airview Bowie Dick; Test Pack, Indicator Sheets (2013), 1 descendant of its own
- K133204: Airview Mini Owie Dick Test Pack (2014), 0 descendants of its own

## Indications for use
The SPSmedical AirView Bowie Dick Test Pack and AirView Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a pre-vacuum sterilizer operating at 134°C the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in AAMI/ANSI ST-46.

Source page: https://510kreport.com/device/K041017
Methodology: https://510kreport.com/methodology