FDA product code MDP: Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
MDP is the FDA product code for separator for therapeutic purposes, membrane automated blood cell/plasma. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MDP reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 3 recalls for MDP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MDP devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-01-06.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code MDP?
MDP is the FDA product code for separator for therapeutic purposes, membrane automated blood cell/plasma. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MDP?
Class III. Typical premarket route: PMA.
Have MDP devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2026-01-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MDP
- Run a recall and safety report across every MDP manufacturer
- Watch product code MDP 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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