Cleared Traditional

trophon2

K250434 · Nanosonics · General Hospital
Aug 2025
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K250434 is an FDA 510(k) clearance for the trophon2, a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II — Special Controls, product code OUJ), submitted by Nanosonics (Macquarie Park, AU). The FDA issued a Cleared decision on August 5, 2025, 172 days after receiving the submission on February 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K250434 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2025
Decision Date August 05, 2025
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570
Definition To Provide High Level Disinfection Of Ultrasound Transducers. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).