510(k) Report

FDA product code · General and plastic surgery

Dressing, Wound And Burn, Occlusive

MGPClass U510(k) required80 decisions since 19911 recall

80 FDA decisions since 1991. 1 recall names this code; it is not Class I. The most-cited predicate is K973036, named by 8 later devices.

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 MGP 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 · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

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

Recalls per year · MGP

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGP

8in 2024

2007: 12009: 12010: 22011: 42013: 72014: 12015: 32016: 12017: 62021: 522022: 32023: 32024: 8
2007high 52 (2021) · low 0 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—01
20100—02
20110—14
20120—00
20130—07
20140—01
20150—03
20160—01
20170—06
20180—00
20190—00
20200—00
20210—052
20220—03
20230—03
20240—08
20250—00
20260—0—
FIG. 1 — MGP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MGP? 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