FDA product code · Ophthalmic

Locator, Metal, Electronic

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

HPMClass II21 CFR 886.4400510(k) exempt4 decisions since 19780 recalls

FDA lists HPM 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. 4 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 HPM 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 · HPM

FDA has decided no HPM device since 2007.

Median 510(k) review, days · HPM

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

Recalls per year · HPM

No recall names HPM since 2007.

Adverse event reports per year · HPM

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

Planning a device in HPM? 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

Locator, Metal, Electronic

What has FDA decided in HPM lately?