FDA product code IDR: Ovens, Paraffin
IDR is the FDA product code for ovens, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ovens, Paraffin |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IDR devices
openFDA lists no recalls for product code IDR.
Frequently asked questions
What is FDA product code IDR?
IDR is the FDA product code for ovens, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDR?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IDR
- Run a recall and safety report across every IDR manufacturer
- Watch product code IDR 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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