# K971971: Browne TST Single Use Bowie-Dick Type Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Board of Directors, Albert Browne, Ltd.
- Decided: Jul 10, 1998 after 407 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 K932057 (1994). 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)
- K932057: Browne TST Single Use Bowie Dick Type Test Pack, Board of Directors, Albert Browne, Ltd. (1994) Summary page 1.

## Indications for use
The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

Source page: https://510kreport.com/device/K971971
Methodology: https://510kreport.com/methodology