# K250434: trophon2

- Pathway: 510(k) (Traditional)
- Applicant: Nanosonics
- Decided: Aug 5, 2025 after 172 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924334 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173865: trophon2, Nanosonics Limited (2018) Summary page 5.

## Indications for use
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain the ultrasound probe. The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge. The trophon2 is suitable for use in general hospital and health care facilities by trained personnel. The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 4 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56°C

Source page: https://510kreport.com/device/K250434
Methodology: https://510kreport.com/methodology