FDA product code · Ophthalmic

Lens, Spectacle (Prescription), For Reading Discomfort

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

NJHClass I21 CFR 886.5844510(k) exempt2 decisions since 19850 recalls

FDA lists NJH 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. 2 FDA decisions since 1985. No recall names this code.

Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

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 NJH 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 · NJH

FDA has decided no NJH device since 2007.

Median 510(k) review, days · NJH

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

Recalls per year · NJH

No recall names NJH since 2007.

Adverse event reports per year · NJH

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code NJH, 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	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in NJH? 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

Related product codes

Other codes under 21 CFR 886.5844.

NAI Lens, Prescription, Color Deficiency HQG Lens, Spectacle, Non-Custom (Prescription)

Lens, Spectacle (Prescription), For Reading Discomfort

Which NJH devices have the deepest lineage?

What has FDA decided in NJH lately?

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