FDA product code · Ophthalmic

Set, Lens, Trial, Ophthalmic

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

HPCClass I21 CFR 886.1405510(k) exempt13 decisions since 19770 recalls

FDA lists HPC 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. 13 FDA decisions since 1977. 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 HPC 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 · HPC

FDA has decided no HPC device since 2007.

Median 510(k) review, days · HPC

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

Recalls per year · HPC

No recall names HPC since 2007.

Adverse event reports per year · HPC

1in 2023

2007high 1 (2023) · low 0 (2007)2025

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

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

Planning a device in HPC? 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

Set, Lens, Trial, Ophthalmic

What has FDA decided in HPC lately?