FDA product code JRK: Evaporator
JRK is the FDA product code for evaporator. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. Devices under JRK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Evaporator |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for JRK devices
openFDA lists no recalls for product code JRK.
Frequently asked questions
What is FDA product code JRK?
JRK is the FDA product code for evaporator. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRK?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JRK
- Run a recall and safety report across every JRK manufacturer
- Watch product code JRK 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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