# K143629: U&U Bowie-Dick Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: May 19, 2015 after 148 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: 2 generations back to K841168 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093199: 3M Comply Bowie- Dick Type Lead Free Test Pack, 3M Company (2009) Summary page 4.

## Indications for use
U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow 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°C /-0°C) temperature difference between the center of the Bowie-Dick Test 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 U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change

Source page: https://510kreport.com/device/K143629
Methodology: https://510kreport.com/methodology