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.
FDA 510(k) Cleared High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist Devices (Product Code OUJ)
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 increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OUJ submissions have been consistent, averaging 146 days recently vs 129 days historically.
OUJ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →