# K984616: Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Feb 4, 1999 after 37 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 K922481 (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)
- K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde, Board of Directors, Albert Browne, Ltd. (1994) Summary page 1.

## Indications for use
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 0.6% glutaraldehyde. The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.

Source page: https://510kreport.com/device/K984616
Methodology: https://510kreport.com/methodology