FDA product code · Ophthalmic

Loupe, Binocular, Low Power

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

HJHClass I21 CFR 886.5120510(k) exempt3 decisions since 19830 recalls

FDA lists HJH 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. 3 FDA decisions since 1983. 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 HJH 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 · HJH

FDA has decided no HJH device since 2007.

Median 510(k) review, days · HJH

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

Recalls per year · HJH

No recall names HJH since 2007.

Adverse event reports per year · HJH

2in 2022

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code HJH, 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	—	2
2020	—	0
2021	—	0
2022	—	2
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HJH? 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

Loupe, Binocular, Low Power

What has FDA decided in HJH lately?