FDA product code JRS: Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
JRS is the FDA product code for purifier, water (absorption, deionization, membrane filter, reverse osmosis). It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. Devices under JRS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) |
| 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 JRS devices
openFDA lists no recalls for product code JRS.
Frequently asked questions
What is FDA product code JRS?
JRS is the FDA product code for purifier, water (absorption, deionization, membrane filter, reverse osmosis). It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRS?
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 JRS
- Run a recall and safety report across every JRS manufacturer
- Watch product code JRS 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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