FDA product code ONM: Radiant Infant Warmer Cabinet
ONM is the FDA product code for radiant infant warmer cabinet. It is a Class II device, regulated under 21 CFR 880.5130 and reviewed by the General Hospital panel. Devices under ONM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer.
Classification
| Field | Value |
|---|---|
| Device name | Radiant Infant Warmer Cabinet |
| Device class | Class II |
| Regulation | 21 CFR 880.5130 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for ONM devices
openFDA lists no recalls for product code ONM.
Frequently asked questions
What is FDA product code ONM?
ONM is the FDA product code for radiant infant warmer cabinet. It is a Class II device, regulated under 21 CFR 880.5130 and reviewed by the General Hospital panel.
What device class is ONM?
Class II, regulation 21 CFR 880.5130. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code ONM
- Run a recall and safety report across every ONM manufacturer
- Watch product code ONM 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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