# K080750: Browne Rapicide Glutaraldehyde Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 12, 2008 after 56 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 K915170 (1992). 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)
- K915170: Pymah Cold Sterilog Glutaraldehyde Monitor, Pymah Corp. (1992) Summary page 2.

## Indications for use
The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.

Source page: https://510kreport.com/device/K080750
Methodology: https://510kreport.com/methodology