FDA product code · Ophthalmic

Shell, Scleral

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

HQTClass II21 CFR 886.3800510(k) exempt4 decisions since 19860 recalls

FDA lists HQT 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. 4 FDA decisions since 1986. 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 HQT 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 · HQT

FDA has decided no HQT device since 2007.

Median 510(k) review, days · HQT

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

Recalls per year · HQT

No recall names HQT since 2007.

Adverse event reports per year · HQT

1in 2009

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
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 — HQT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HQT? 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

Shell, Scleral

What has FDA decided in HQT lately?