# K965154: TST Control Integrator for Steam Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Sep 19, 1997 after 270 days
- Product code: LRT (Indicator, Sterilization)
- 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 K902958 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902958: TST Control Integrator for Steam Autoclave, Board of Directors, Albert Browne, Ltd. (1990) Summary page 2.

## Most influential descendants
- K062651: Prochem Ext Chemical Integrator (2007), 0 descendants of its own

## Indications for use
The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters (270°F, 3 min.) necessary for sterilization have been achieved.

Source page: https://510kreport.com/device/K965154
Methodology: https://510kreport.com/methodology