510(k) Report

FDA product code · Ophthalmic

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

QITClass IIIPMA required1 decision since 20190 recalls

1 FDA decision since 2019. No recall names this code.

Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error.

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 QIT 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 · QIT

9in 2025

2019: 12020: 42021: 42022: 42023: 72024: 52025: 92026 (partial year): 1
2007high 9 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIT

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

Recalls per year · QIT

No recall names QIT since 2007.

Adverse event reports per year · QIT

5in 2025

2019: 12021: 12022: 32023: 42024: 22025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QIT, 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
20191—01
20204—00
20214—01
20224—03
20237—04
20245—02
20259—05
20261—0—
FIG. 1 — QIT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QIT? 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