# K103126: Trophon Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Nanosonics Limited
- Decided: Mar 3, 2011 after 132 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 K915170 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092346: Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171, Serim Research Corp. (2010) Summary page 1.

## Most influential descendants
- K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B) (2024), 0 descendants of its own

## Indications for use
The Trophon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Trophon EPR chamber. The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

Source page: https://510kreport.com/device/K103126
Methodology: https://510kreport.com/methodology