FDA product code · Ophthalmic

Tester, Color Vision

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

HITClass I21 CFR 886.1170510(k) exempt9 decisions since 19810 recalls

FDA lists HIT 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. 9 FDA decisions since 1981. 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 HIT 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 · HIT

FDA has decided no HIT device since 2007.

Median 510(k) review, days · HIT

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

Recalls per year · HIT

No recall names HIT since 2007.

Adverse event reports per year · HIT

No MAUDE report names HIT since 2007.

View these four charts as a table

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

Planning a device in HIT? 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

Tester, Color Vision

What has FDA decided in HIT lately?