510(k) Report

FDA product code · Gastroenterology and urology

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

MDPClass IIIPMA required3 decisions since 19830 recalls

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, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

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

2009: 12010: 22011: 32015: 32016: 22017: 12018: 22019: 22020: 42021: 42022: 52023: 32024: 42025: 22026 (partial year): 3
2007high 5 (2022) · low 0 (2007)2026

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

2013: 32014: 12015: 52016: 132017: 142018: 132019: 132020: 82021: 102022: 82023: 162024: 352025: 54
2007high 54 (2025) · low 0 (2007)2025

MAUDE reports naming product code MDP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20102—00
20113—00
20120—00
20130—03
20140—01
20153—05
20162—013
20171—014
20182—013
20192—013
20204—08
20214—010
20225—08
20233—016
20244—035
20252—054
20263—0—
FIG. 1 — MDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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