# K250172: Green Card Bowie-Dick Test (BD115)

- Pathway: 510(k) (Special)
- Applicant: Steritec Products, Inc. (A Getinge Company)
- Decided: Feb 20, 2025 after 30 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 K024293 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024293: Bowie-Dick Mini Pak, Model BD 115, Steritec Products, Inc. (2003) Summary page 5.

## Indications for use
The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270'F (1320C) and 273oF (134oC) 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 20C 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/K250172
Methodology: https://510kreport.com/methodology