# K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B)

- Pathway: 510(k) (Traditional)
- Applicant: True Indicating, LLC
- Decided: Jun 26, 2024 after 264 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: 3 generations back to K915170 (1992). 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)
- K103126: Trophon Chemical Indicator, Nanosonics Limited (2011) Summary page 5.

## Indications for use
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon@ EPR and trophon@ 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon@ EPR and trophon@ 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

Source page: https://510kreport.com/device/K233413
Methodology: https://510kreport.com/methodology