FDA product code RDE: Sewing Machine
RDE is the FDA product code for sewing machine. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 1 recall for RDE devices, 1 initiated in the last five years.
Definition
A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine.
Classification
| Field | Value |
|---|---|
| Device name | Sewing Machine |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for RDE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-26.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code RDE?
RDE is the FDA product code for sewing machine. It is a Not classified device, reviewed by the Unknown panel.
What device class is RDE?
Not classified.
Have RDE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code RDE
- Run a recall and safety report across every RDE manufacturer
- Watch product code RDE 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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