FDA product code OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
OUJ is the FDA product code for high level disinfection reprocessing instrument for ultrasonic transducers, mist. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under OUJ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 137 days (median 128); 146 days on average over the last three years. FDA has posted 1 recall for OUJ devices, 1 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Device class | Class II |
| Regulation | 21 CFR 892.1570 |
| Review panel | HO — General Hospital |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OUJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 125 |
| 2024 | 1 | 120 |
| 2025 | 1 | 172 |
Compare with all 510(k) review times · Search every OUJ clearance
Top OUJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nanosonics Limited | 3 | 2024-09-27 |
| Nanosonics | 1 | 2025-08-05 |
Most recent OUJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250434 | Nanosonics | trophon2 | 2025-08-05 | 172 |
| K241536 | Nanosonics Limited | trophon Wireless Ultrasound Probe Holder | 2024-09-27 | 120 |
| K173865 | Nanosonics Limited | trophon2 | 2018-04-24 | 125 |
| K103059 | Nanosonics Limited | TROPHON | 2011-02-24 | 132 |
Recalls for OUJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OUJ?
OUJ is the FDA product code for high level disinfection reprocessing instrument for ultrasonic transducers, mist. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the General Hospital panel.
What device class is OUJ?
Class II, regulation 21 CFR 892.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUJ?
Across 4 cleared submissions the average was 137 days from receipt to decision (median 128).
Which companies have the most OUJ clearances?
Nanosonics Limited (3); Nanosonics (1).
Have OUJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code OUJ
- Run a recall and safety report across every OUJ manufacturer
- Watch product code OUJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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