FDA product code · General and plastic surgery

Protector, Wound, Plastic

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

EYFClass I21 CFR 878.4014510(k) required5 decisions since 19830 recalls

5 FDA decisions since 1983. 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, general and plastic surgery panel

Twenty years of EYF 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 · EYF

FDA has decided no EYF device since 2007.

Median 510(k) review, days · EYF

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

Recalls per year · EYF

No recall names EYF since 2007.

Adverse event reports per year · EYF

No MAUDE report names EYF since 2007.

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	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — EYF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EYF? 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 878.4014.

PXY Irrigation Kit (Wounds)LZM Guard, Skin Graft PYK Venous Ulcer Kit PYL Wound Drainage Kit PKD Laceration Tray OVR Kit, First Aid, Talking NAB Gauze / Sponge,Nonresorbable For External Use OHO First Aid Kit Without Drug PYJ Ulcer Wound Tray MAC Decontamination Kit

Protector, Wound, Plastic

What has FDA decided in EYF lately?

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