510(k) Report

FDA product code · Ophthalmic

Corneal Storage Media With Preservatives Including Anti-Fungal

QCWClass II21 CFR 886.4320510(k) required1 decision since 20220 recalls

1 FDA decision since 2022. No recall names this code.

Media to preserve human corneas while in storage.

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 QCW 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 · QCW

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QCW

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

Recalls per year · QCW

No recall names QCW since 2007.

Adverse event reports per year · QCW

No MAUDE report names QCW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QCW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QCW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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