# K024293: Bowie-Dick Mini Pak, Model BD 115

- Pathway: 510(k) (Abbreviated)
- Applicant: Steritec Products, Inc.
- Decided: Aug 11, 2003 after 230 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250172: Green Card Bowie-Dick Test (BD115) (2025), 0 descendants of its own

## Recalls of this device
- Jul 15, 2009 · Not classified · Z-1531-2010: This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data o

## Indications for use
SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

Source page: https://510kreport.com/device/K024293
Methodology: https://510kreport.com/methodology