FDA product code · Ophthalmic

Drum, Opticokinetic

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

HOWClass I21 CFR 886.1200510(k) exempt1 decision since 19820 recalls

FDA lists HOW 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 1982. 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 HOW 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 · HOW

FDA has decided no HOW device since 2007.

Median 510(k) review, days · HOW

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

Recalls per year · HOW

No recall names HOW since 2007.

Adverse event reports per year · HOW

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

Planning a device in HOW? 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

Drum, Opticokinetic

What has FDA decided in HOW lately?