FDA product code · Ophthalmic

Plug, Scleral

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

LXPClass II21 CFR 886.4155510(k) required10 decisions since 19830 recalls

10 FDA decisions since 1983. No recall names this code. The most-cited predicate is K854507, named by 2 later devices.

Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.

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, ophthalmic panel

Twenty years of LXP 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 · LXP

FDA has decided no LXP device since 2007.

Median 510(k) review, days · LXP

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

Recalls per year · LXP

No recall names LXP since 2007.

Adverse event reports per year · LXP

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

Planning a device in LXP? 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

Plug, Scleral

Which predicates do LXP devices cite most?

Which LXP devices have the deepest lineage?

What has FDA decided in LXP lately?