FDA product code · Gastroenterology and urology
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
3 FDA decisions since 1983. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MDP 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 · MDP
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MDP
Too few MDP 510(k)s in any year since 2007 to give a median.
Recalls per year · MDP
No recall names MDP since 2007.
Adverse event reports per year · MDP
54in 2025
MAUDE reports naming product code MDP, 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 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 3 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 13 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 2 | — | 0 | 13 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 4 | — | 0 | 8 |
| 2021 | 4 | — | 0 | 10 |
| 2022 | 5 | — | 0 | 8 |
| 2023 | 3 | — | 0 | 16 |
| 2024 | 4 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 54 |
| 2026 | 3 | — | 0 | — |
Planning a device in MDP? 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