510(k) Report

FDA product code · Ophthalmic

Telescope, Implantable, Miniature

NCJClass IIIPMA required1 decision since 20100 recalls

1 FDA decision since 2010. 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 NCJ 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 · NCJ

1in 2024

2010: 42011: 22012: 22013: 42014: 32015: 12016: 22017: 12019: 12024: 1
2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCJ

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

Recalls per year · NCJ

No recall names NCJ since 2007.

Adverse event reports per year · NCJ

3in 2016

2012: 12014: 42016: 3
2007high 4 (2014) · low 0 (2007)2025

MAUDE reports naming product code NCJ, 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—00
20104—00
20112—00
20122—01
20134—00
20143—04
20151—00
20162—03
20171—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—
FIG. 1 — NCJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NCJ? 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