# K132372: Steritec Green Card Pack Bowie-Dick Test

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Nov 26, 2013 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
SteriTec Green Card Pack Bowie-Dick Test is a single use device designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C and 134°C for 3.5 minutes. The Indicator card within the Green Card Pak will demonstrate a uniform color change from purple to green 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 indicator card within the Green Card Pack will demonstrate a non-uniform color change.

Source page: https://510kreport.com/device/K132372
Methodology: https://510kreport.com/methodology