FDA product code · Ophthalmic

Spectacle, Magnifying

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

HOIClass I21 CFR 886.5840510(k) exempt11 decisions since 19800 recalls

FDA lists HOI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 11 FDA decisions since 1980. 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 HOI 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 · HOI

FDA has decided no HOI device since 2007.

Median 510(k) review, days · HOI

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

Recalls per year · HOI

No recall names HOI since 2007.

Adverse event reports per year · HOI

1in 2025

2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code HOI, 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	—	1
2018	—	2
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	3
2025	—	1
2026	—	—

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

Planning a device in HOI? 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

Spectacle, Magnifying

What has FDA decided in HOI lately?