510(k) Report

FDA product code · Ophthalmic

Magnifier, Hand-Held, Low-Vision

HJFClass I21 CFR 886.5540510(k) exempt1 decision since 19820 recalls

FDA lists HJF 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 1982. 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 HJF 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 · HJF

FDA has decided no HJF device since 2007.

Median 510(k) review, days · HJF

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

Recalls per year · HJF

No recall names HJF since 2007.

Adverse event reports per year · HJF

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code HJF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HJF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HJF? 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

What has FDA decided in HJF lately?

  • K820375Plastic or Glass MagnifierGazelle Corp. · 1982

The one HJF decision →

Related product codes

Other codes under 21 CFR 886.5540.

HKC Spectacle Microscope, Low-Vision