FDA product code PHO: Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
PHO is the FDA product code for normothermic preservation system for transplantation of initially unacceptable donor lungs. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under PHO reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 1 recall for PHO devices, 1 initiated in the last five years.
Definition
Preservation of donor lungs for transplantation.
Classification
| Field | Value |
|---|---|
| Device name | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for PHO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-04-08.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code PHO?
PHO is the FDA product code for normothermic preservation system for transplantation of initially unacceptable donor lungs. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is PHO?
Class III. Typical premarket route: PMA.
Have PHO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code PHO
- Run a recall and safety report across every PHO manufacturer
- Watch product code PHO 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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