FDA product code · Ophthalmic

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

HPOClass II21 CFR 886.4440510(k) exempt3 decisions since 19830 recalls

FDA lists HPO 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 HPO 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 · HPO

FDA has decided no HPO device since 2007.

Median 510(k) review, days · HPO

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

Recalls per year · HPO

No recall names HPO since 2007.

Adverse event reports per year · HPO

1in 2008

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code HPO, 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	—	1
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 — HPO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HPO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in HPO lately?