FDA product code · Neurology

Monitor, Blood-Flow, Cerebral, Thermal Diffusion

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

LMEClass IIIPathway set case by case1 decision since 19850 recalls

1 FDA decision since 1985. 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, neurology panel

Twenty years of LME 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 · LME

FDA has decided no LME device since 2007.

Median 510(k) review, days · LME

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

Recalls per year · LME

No recall names LME since 2007.

Adverse event reports per year · LME

No MAUDE report names LME 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 — LME by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LME? 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

Monitor, Blood-Flow, Cerebral, Thermal Diffusion

What has FDA decided in LME lately?