510(k) Report

FDA product code · Ophthalmic

Keratome, Water Jet

MYDClass I21 CFR 886.4370510(k) required1 decision since 20000 recalls

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 MYD 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 · MYD

FDA has decided no MYD device since 2007.

Median 510(k) review, days · MYD

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

Recalls per year · MYD

No recall names MYD since 2007.

Adverse event reports per year · MYD

No MAUDE report names MYD 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
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MYD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MYD? 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

Which MYD devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 20004generations

What has FDA decided in MYD lately?

  • K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000

The one MYD decision →

Related product codes

Other codes under 21 CFR 886.4370.

NKY Blade, Keratome, ReprocessedHNO Keratome, Ac-PoweredHMY Keratome, Battery-Powered