510(k) Report

FDA product code · Ophthalmic

Apparatus, Cautery, Radiofrequency, Battery-Powered

HQQClass II21 CFR 886.4100510(k) required3 decisions since 19880 recalls

3 FDA decisions since 1988. 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 HQQ 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 · HQQ

FDA has decided no HQQ device since 2007.

Median 510(k) review, days · HQQ

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

Recalls per year · HQQ

No recall names HQQ since 2007.

Adverse event reports per year · HQQ

3in 2021

2021: 3
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code HQQ, not matched to any one device; reports are not rates.

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—03
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HQQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HQQ? 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 886.4100.