510(k) Report

FDA product code · Ophthalmic

Stereoscope, Ac-Powered

HJQClass I21 CFR 886.1870510(k) exempt1 decision since 19830 recalls

FDA lists HJQ 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 1983. 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 HJQ 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 · HJQ

FDA has decided no HJQ device since 2007.

Median 510(k) review, days · HJQ

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

Recalls per year · HJQ

No recall names HJQ since 2007.

Adverse event reports per year · HJQ

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

Planning a device in HJQ? 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 HJQ lately?

  • K830625Cyto-StainRichard-Allan Medical Ind., Inc. · 1983

The one HJQ decision →

Related product codes

Other codes under 21 CFR 886.1870.

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