FDA product code MON: System, Hemodialysis, Remote Accessories
MON is the FDA product code for system, hemodialysis, remote accessories. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under MON reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Hemodialysis, Remote Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for MON devices
openFDA lists no recalls for product code MON.
Frequently asked questions
What is FDA product code MON?
MON is the FDA product code for system, hemodialysis, remote accessories. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is MON?
Class I, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MON
- Run a recall and safety report across every MON manufacturer
- Watch product code MON 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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