FDA product code · Ophthalmic

Injector, Capsular Tension Ring

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

NCEClass I21 CFR 886.4300510(k) required3 decisions since 20000 recalls

3 FDA decisions since 2000. 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 NCE 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 · NCE

FDA has decided no NCE device since 2007.

Median 510(k) review, days · NCE

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

Recalls per year · NCE

No recall names NCE since 2007.

Adverse event reports per year · NCE

1in 2023

2007high 1 (2023) · low 0 (2007)2025

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

Planning a device in NCE? 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

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Other codes under 21 CFR 886.4300.

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Injector, Capsular Tension Ring

What has FDA decided in NCE lately?

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