510(k) Report

FDA product code · Ophthalmic

Monitor, Eye Movement, Diagnostic

HMCClass II21 CFR 886.1510510(k) required1 decision since 19940 recalls

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 HMC 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 · HMC

FDA has decided no HMC device since 2007.

Median 510(k) review, days · HMC

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

Recalls per year · HMC

No recall names HMC since 2007.

Adverse event reports per year · HMC

No MAUDE report names HMC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HMC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HMC? 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

What has FDA decided in HMC lately?

  • K931678Orthomet LHMC Femoral StemOrthomet, Inc. · 1994

The one HMC decision →

Related product codes

Other codes under 21 CFR 886.1510.

HLL Monitor, Eye Movement