FDA product code · Ophthalmic

Rack, Skiascopic

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

HMHClass I21 CFR 886.1750510(k) exempt2 decisions since 19840 recalls

FDA lists HMH 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. 2 FDA decisions since 1984. 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 HMH 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 · HMH

FDA has decided no HMH device since 2007.

Median 510(k) review, days · HMH

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

Recalls per year · HMH

No recall names HMH since 2007.

Adverse event reports per year · HMH

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

Planning a device in HMH? 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

Rack, Skiascopic

What has FDA decided in HMH lately?