FDA product code OUW: Infant Positioner, Rx, Use In Highly Monitored Setting
OUW is the FDA product code for infant positioner, rx, use in highly monitored setting. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OUW. The average 510(k) review took 114 days (median 114). FDA has posted 2 recalls for OUW devices.
Definition
Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Infant Positioner, Rx, Use In Highly Monitored Setting |
| Device class | Class I |
| Regulation | 21 CFR 880.5680 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OUW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 114 |
Compare with all 510(k) review times · Search every OUW clearance
Top OUW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neonatal Loving Kare, Inc. | 1 | 2018-01-18 |
Most recent OUW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172962 | Neonatal Loving Kare, Inc. | Nurture Rest | 2018-01-18 | 114 |
Recalls for OUW devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-07-26.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code OUW?
OUW is the FDA product code for infant positioner, rx, use in highly monitored setting. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel.
What device class is OUW?
Class I, regulation 21 CFR 880.5680. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUW?
Across 1 cleared submissions the average was 114 days from receipt to decision (median 114).
Which companies have the most OUW clearances?
Neonatal Loving Kare, Inc. (1).
Have OUW devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2017-07-26.
Next steps
- Run an FDA pathway report with predicate devices for product code OUW
- Run a recall and safety report across every OUW manufacturer
- Watch product code OUW 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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