FDA product code · Neurology

Monitor, Intracranial Pressure, Implanted

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

LIIClass 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, neurology panel

Twenty years of LII 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 · LII

FDA has decided no LII device since 2007.

Median 510(k) review, days · LII

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

Recalls per year · LII

No recall names LII since 2007.

Adverse event reports per year · LII

2in 2023

2007high 2 (2023) · low 0 (2007)2025

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

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	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	2
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in LII? 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, Intracranial Pressure, Implanted

What has FDA decided in LII lately?