FDA Product Code OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
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).
Leading manufacturers include Nanosonics Limited and Nanosonics.
4
Total
4
Cleared
137d
Avg days
2011
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
172d
recently vs 126d historically
FDA 510(k) Cleared High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist Devices (Product Code OUJ)
4 devices
Cleared
Aug 05, 2025
trophon2
Nanosonics
General Hospital
172d
Cleared
Sep 27, 2024
trophon Wireless Ultrasound Probe Holder
Nanosonics Limited
General Hospital
120d
Cleared
Apr 24, 2018
trophon2
Nanosonics Limited
General Hospital
125d
Cleared
Feb 24, 2011
TROPHON
Nanosonics Limited
General Hospital
132d
About Product Code OUJ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OUJ since 2011, with 4 receiving FDA clearance (average review time: 137 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OUJ Product Code
Recent submissions under OUJ have taken an average of 172 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
OUJ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →