FDA product code · Ophthalmic

Prism, Bar, Ophthalmic

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

HKWClass I21 CFR 886.1650510(k) exempt2 decisions since 19850 recalls

FDA lists HKW 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. 2 FDA decisions since 1985. 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 HKW 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 · HKW

FDA has decided no HKW device since 2007.

Median 510(k) review, days · HKW

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

Recalls per year · HKW

No recall names HKW since 2007.

Adverse event reports per year · HKW

1in 2020

2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code HKW, 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	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HKW? 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

Prism, Bar, Ophthalmic

What has FDA decided in HKW lately?