FDA product code · General and plastic surgery

Wound Dressing Kit

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

MCYClass II21 CFR 880.507524 decisions since 199081 recalls

24 FDA decisions since 1990. 81 recalls name this code, 5 of them Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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 MCY 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 · MCY

FDA has decided no MCY device since 2007.

Median 510(k) review, days · MCY

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

Recalls per year · MCY

1in 2024

2007high 45 (2011) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MCY

3in 2025

2007high 10 (2024) · low 0 (2007)2025

MAUDE reports naming product code MCY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	19	0
2008	—	0	0
2009	—	3	0
2010	—	0	0
2011	—	45	0
2012	—	0	3
2013	—	0	0
2014	—	3 (3)	1
2015	—	0	2
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	1
2020	—	0	9
2021	—	0	3
2022	—	0	0
2023	—	2 (1)	0
2024	—	1	10
2025	—	0	3
2026	—	7 (1)	—

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

Planning a device in MCY? 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

Related product codes

Other codes under 21 CFR 880.5075.

MHW Dressing, Compression FQM Bandage, Elastic OXQ Dressing Change Tray

Wound Dressing Kit

What has FDA decided in MCY lately?

What has been recalled in MCY lately?

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