FDA product code · Obstetrics and gynecology

Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

Name: FDA decisions, review times, recalls and adverse event reports for product code MCI
Creator: 510(k) Report

MCIClass IIIPMA required1 decision since 19820 recalls

1 FDA decision since 1982. 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, obstetrics and gynecology panel

Twenty years of MCI 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 · MCI

FDA has decided no MCI device since 2007.

Median 510(k) review, days · MCI

Too few MCI 510(k)s in any year since 2007 to give a median.

Recalls per year · MCI

No recall names MCI since 2007.

Adverse event reports per year · MCI

No MAUDE report names MCI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MCI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MCI? 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

Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

What has FDA decided in MCI lately?