Cleared Traditional

K250434 - trophon2 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K250434 is an FDA 510(k) clearance for the trophon2. Classified as High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (product code OUJ), Class II - Special Controls.

Submitted by Nanosonics (Macquarie Park, AU). The FDA issued a Cleared decision on August 5, 2025 after a review of 172 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 892.1570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K250434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 128d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.