# K120435: Browne Aldahol Glutaraldehyde Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jun 4, 2012 after 112 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 K924681 (1993). 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)
- K924681: Glutaraldehyde Monitors, Pymah Corp. (1993) Summary page 2.

## Indications for use
The Browne Aldahol Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Aldahol V High-Level Disinfectant. The purpose of the Browne Aldahol Glutaraldehyde Indicator is to monitor glutaraldehyde concentration greater than 1.8%.

Source page: https://510kreport.com/device/K120435
Methodology: https://510kreport.com/methodology