FDA product code · Gastroenterology and urology
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
3 FDA decisions since 2019. No recall names this code.
Preservation of donor lungs for transplantation.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PHO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PHO
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PHO
Too few PHO 510(k)s in any year since 2007 to give a median.
Recalls per year · PHO
No recall names PHO since 2007.
Adverse event reports per year · PHO
8in 2022
MAUDE reports naming product code PHO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | — | 0 | 8 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 5 | — | 0 | — |
Planning a device in PHO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report