FDA product code · Ophthalmic

Lens, Fundus, Hruby, Diagnostic

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

HJIClass I21 CFR 886.1395510(k) exempt8 decisions since 19760 recalls

FDA lists HJI 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. 8 FDA decisions since 1976. 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 HJI 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 · HJI

FDA has decided no HJI device since 2007.

Median 510(k) review, days · HJI

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

Recalls per year · HJI

No recall names HJI since 2007.

Adverse event reports per year · HJI

11in 2023

2007high 11 (2023) · low 0 (2007)2025

MAUDE reports naming product code HJI, 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	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	1
2022	—	0
2023	—	11
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — HJI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HJI? 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

Lens, Fundus, Hruby, Diagnostic

What has FDA decided in HJI lately?