FDA product code · General and plastic surgery

Wound Dressings With Hydrocortisone

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

SEKClass U510(k) required2 decisions since 19890 recalls

2 FDA decisions since 1989. No recall names this code.

A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound

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 SEK 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 · SEK

FDA has decided no SEK device since 2007.

Median 510(k) review, days · SEK

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

Recalls per year · SEK

No recall names SEK since 2007.

Adverse event reports per year · SEK

No MAUDE report names SEK 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 — SEK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SEK? 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

Wound Dressings With Hydrocortisone

What has FDA decided in SEK lately?