FDA product code REN: Particle-Size Measuring Instrument
REN is the FDA product code for particle-size measuring instrument. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 3 recalls for REN devices, 3 initiated in the last five years.
Definition
Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample.
Classification
| Field | Value |
|---|---|
| Device name | Particle-Size Measuring Instrument |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for REN devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-04-07.
| Year | Recalls |
|---|---|
| 2022 | 3 |
Frequently asked questions
What is FDA product code REN?
REN is the FDA product code for particle-size measuring instrument. It is a Not classified device, reviewed by the Unknown panel.
What device class is REN?
Not classified.
Have REN devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2022-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code REN
- Run a recall and safety report across every REN manufacturer
- Watch product code REN 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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