FDA product code · Ophthalmic

Anomaloscope

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

HIWClass I21 CFR 886.1070510(k) exempt3 decisions since 19860 recalls

FDA lists HIW 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 1986. 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 HIW 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 · HIW

FDA has decided no HIW device since 2007.

Median 510(k) review, days · HIW

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

Recalls per year · HIW

No recall names HIW since 2007.

Adverse event reports per year · HIW

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

Planning a device in HIW? 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

Anomaloscope

What has FDA decided in HIW lately?