FDA product code · Ophthalmic

Inserter/Remover Contact Lens

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

KYEClass I21 CFR 886.5420510(k) exempt12 decisions since 19780 recalls

FDA lists KYE 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. 12 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 KYE 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 · KYE

FDA has decided no KYE device since 2007.

Median 510(k) review, days · KYE

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

Recalls per year · KYE

No recall names KYE since 2007.

Adverse event reports per year · KYE

1in 2018

2007high 1 (2018) · low 0 (2007)2025

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

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

Planning a device in KYE? 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

Inserter/Remover Contact Lens

What has FDA decided in KYE lately?