# K103059: Trophon

- Pathway: 510(k) (Traditional)
- Applicant: Nanosonics Limited
- Decided: Feb 24, 2011 after 132 days
- Product code: OUJ (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924334 (1994). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5, Cs Medical, LLC (2005) Summary page 1.
- K970230: Sporox, Reckitt Benckiser, Inc. (1997) Summary page 1.

## Most influential descendants
- K173865: trophon2 (2018), 2 descendants of its own
- K250434: trophon2 (2025), 0 descendants of its own
- K241536: trophon Wireless Ultrasound Probe Holder (2024), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1602-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Trophon EPIR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device. The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers. The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel. The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge. The Trophon Disinfectant should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 560C

Source page: https://510kreport.com/device/K103059
Methodology: https://510kreport.com/methodology