510(k) Report

FDA product code · Ophthalmic

Button, Iris, Eye, Artificial

NCKClass I21 CFR 886.3200510(k) exempt1 decision since 20000 recalls

FDA lists NCK 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. 1 FDA decision 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 NCK 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 · NCK

FDA has decided no NCK device since 2007.

Median 510(k) review, days · NCK

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

Recalls per year · NCK

No recall names NCK since 2007.

Adverse event reports per year · NCK

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code NCK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—02
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NCK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NCK? 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

What has FDA decided in NCK lately?

  • K001326Natural-Iris Pre-Pigmented Corneal ButtonOcular Concepts, LLC · 2000

The one NCK decision →

Related product codes

Other codes under 21 CFR 886.3200.

HQH Eye, Artificial, Non-Custom