FDA product code · Ophthalmic

Drum, Eye Knife Test

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

HMSClass I21 CFR 886.4230510(k) exempt1 decision since 19940 recalls

FDA lists HMS 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 1994. 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 HMS 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 · HMS

FDA has decided no HMS device since 2007.

Median 510(k) review, days · HMS

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

Recalls per year · HMS

No recall names HMS since 2007.

Adverse event reports per year · HMS

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

Planning a device in HMS? 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, Eye Knife Test

What has FDA decided in HMS lately?