# K062651: Prochem Ext Chemical Integrator

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Mar 15, 2007 after 189 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 K902958 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965154: TST Control Integrator for Steam Autoclave, Albert Browne, Ltd. (1997) Summary page 1.
- K002937: TST Control Integrator for Steam Sterilizers, Albert Browne, Ltd. (2001) Summary page 1.
- K902958: TST Control Integrator for Steam Autoclave, Board of Directors, Albert Browne, Ltd. (1990) Summary page 1.

## Indications for use
Raven ProChem EXT chemical integrator is an integrating chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 1210C, 20 minutes; 132 0C, 8.5 minutes; 134 0C, 7.5 minutes and 135°C, 7 minutes.

Source page: https://510kreport.com/device/K062651
Methodology: https://510kreport.com/methodology