FDA product code · Ophthalmic

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

MSIClass IIIPMA required2 decisions since 19890 recalls

2 FDA decisions since 1989. 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, ophthalmic panel

Twenty years of MSI 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 · MSI

FDA has decided no MSI device since 2007.

Median 510(k) review, days · MSI

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

Recalls per year · MSI

No recall names MSI since 2007.

Adverse event reports per year · MSI

1in 2022

2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code MSI, 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	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in MSI? 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

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What has FDA decided in MSI lately?