510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250434Substantially Equivalent

trophon2

Nanosonics Limited, Macquarie Park, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250434 is the FDA 510(k) clearance record for trophon2, a class II device, cleared for Nanosonics on under FDA product code OUJ (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist). FDA's definition for product code OUJ reads: "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...". FDA records list 7 510(k) clearances for Nanosonics, from to . As of , FDA records show no recalls naming K250434.

Clearance record

Decision date
Received
(172 days to decision)
Product code
OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Nanosonics 7-11 Talavera Rd., Macquarie Park, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUJ

Trailing 12 months

FDA records hold no clearances under product code OUJ in the trailing twelve months.

FDA records show no clearances under product code OUJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260