FDA product code · Ophthalmic

Telescope, Spectacle, Low-Vision

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

HKKClass I21 CFR 886.5870510(k) exempt2 decisions since 19870 recalls

FDA lists HKK 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 1987. 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 HKK 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 · HKK

FDA has decided no HKK device since 2007.

Median 510(k) review, days · HKK

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

Recalls per year · HKK

No recall names HKK since 2007.

Adverse event reports per year · HKK

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code HKK, 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	—	2
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 — HKK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HKK? 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

Related product codes

Other codes under 21 CFR 886.5870.

HKB Telescope, Hand-Held, Low-Vision

Telescope, Spectacle, Low-Vision

What has FDA decided in HKK lately?

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