FDA product code OJU: Skin Prep Tray
OJU is the FDA product code for skin prep tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OJU. The average 510(k) review took 16 days (median 16). FDA has posted 21 recalls for OJU devices, 11 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Classification
| Field | Value |
|---|---|
| Device name | Skin Prep Tray |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OJU clearance
Top OJU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmaseal Div., Baxter Healthcare Corp. | 1 | 1978-11-08 |
Most recent OJU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781797 | Pharmaseal Div., Baxter Healthcare Corp. | PREP TRAY, PREOPERATIVE SKIN | 1978-11-08 | 16 |
Recalls for OJU devices
21 product recalls in 17 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2020 | 3 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code OJU?
OJU is the FDA product code for skin prep tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is OJU?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OJU?
Across 1 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most OJU clearances?
Pharmaseal Div., Baxter Healthcare Corp. (1).
Have OJU devices been recalled?
Yes: 21 product recalls across 17 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code OJU
- Run a recall and safety report across every OJU manufacturer
- Watch product code OJU 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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