510(k) Report

FDA product code · Ophthalmic

Marker, Sclera

HMQClass I21 CFR 886.4570510(k) exempt0 decisions0 recalls

FDA lists HMQ 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. 0 FDA decisions. 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 HMQ 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 · HMQ

FDA has decided no HMQ device since 2007.

Median 510(k) review, days · HMQ

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

Recalls per year · HMQ

No recall names HMQ since 2007.

Adverse event reports per year · HMQ

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

Planning a device in HMQ? 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

Related product codes

Other codes under 21 CFR 886.4570.

HRP Pen, Marking, SurgicalHMR Marker, Ocular