FDA product code · Ophthalmic

Simulatan (Including Crossed Cylinder)

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

HORClass I21 CFR 886.1840510(k) exempt1 decision since 19870 recalls

FDA lists HOR 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. 1 FDA decision since 1987. 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 HOR 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 · HOR

FDA has decided no HOR device since 2007.

Median 510(k) review, days · HOR

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

Recalls per year · HOR

No recall names HOR since 2007.

Adverse event reports per year · HOR

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

Planning a device in HOR? 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

Simulatan (Including Crossed Cylinder)

What has FDA decided in HOR lately?