FDA product code PRN: Pediatric Position Holder
PRN is the FDA product code for pediatric position holder. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel. Devices under PRN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Position Holder |
| Device class | Class I |
| Regulation | 21 CFR 880.5680 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PRN devices
openFDA lists no recalls for product code PRN.
Frequently asked questions
What is FDA product code PRN?
PRN is the FDA product code for pediatric position holder. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel.
What device class is PRN?
Class I, regulation 21 CFR 880.5680. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PRN
- Run a recall and safety report across every PRN manufacturer
- Watch product code PRN 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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