FDA product code · Ophthalmic

Reader, Prism, Ophthalmic

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

HJXClass I21 CFR 886.5810510(k) exempt1 decision since 20000 recalls

FDA lists HJX 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. 1 FDA decision since 2000. 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 HJX 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 · HJX

FDA has decided no HJX device since 2007.

Median 510(k) review, days · HJX

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

Recalls per year · HJX

No recall names HJX since 2007.

Adverse event reports per year · HJX

No MAUDE report names HJX 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 — HJX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HJX? 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

Reader, Prism, Ophthalmic

What has FDA decided in HJX lately?