FDA product code LNR: System, Photopheresis, Extracorporeal
LNR is the FDA product code for system, photopheresis, extracorporeal. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under LNR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 10 recalls for LNR devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Photopheresis, Extracorporeal |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LNR devices
10 product recalls in 10 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-05-16.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LNR?
LNR is the FDA product code for system, photopheresis, extracorporeal. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LNR?
Class III. Typical premarket route: PMA.
Have LNR devices been recalled?
Yes: 10 product recalls across 10 recall events; the most recent began 2025-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code LNR
- Run a recall and safety report across every LNR manufacturer
- Watch product code LNR 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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