FDA product code · Ophthalmic

Reader, Bar, Ophthalmic

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

HJYClass I21 CFR 886.5800510(k) exempt1 decision since 19780 recalls

FDA lists HJY 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 1978. 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 HJY 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 · HJY

FDA has decided no HJY device since 2007.

Median 510(k) review, days · HJY

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

Recalls per year · HJY

No recall names HJY since 2007.

Adverse event reports per year · HJY

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

Planning a device in HJY? 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, Bar, Ophthalmic

What has FDA decided in HJY lately?