FDA product code · Ophthalmic

Spectacle, Operating (Loupe), Ophthalmic

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

HOHClass I21 CFR 886.4770510(k) exempt3 decisions since 19810 recalls

FDA lists HOH 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. 3 FDA decisions since 1981. 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 HOH 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 · HOH

FDA has decided no HOH device since 2007.

Median 510(k) review, days · HOH

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

Recalls per year · HOH

No recall names HOH since 2007.

Adverse event reports per year · HOH

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

Planning a device in HOH? 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, Operating (Loupe), Ophthalmic

What has FDA decided in HOH lately?