FDA product code · Ophthalmic

Instrument, Visual Field, Laser

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

HPJClass II21 CFR 886.1360510(k) required5 decisions since 19780 recalls

5 FDA decisions 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 HPJ 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 · HPJ

FDA has decided no HPJ device since 2007.

Median 510(k) review, days · HPJ

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

Recalls per year · HPJ

No recall names HPJ since 2007.

Adverse event reports per year · HPJ

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

Planning a device in HPJ? 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

Instrument, Visual Field, Laser

What has FDA decided in HPJ lately?