510(k) Report

FDA product code · General hospital

Cover, Barrier, Protective

MMPClass II21 CFR 878.4370510(k) required15 decisions since 198219 recalls

15 FDA decisions since 1982. 19 recalls name this code, 0 of them Class I. The most-cited predicate is K931417, named by 5 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 hospital panel

Twenty years of MMP 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 · MMP

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMP

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

Recalls per year · MMP

1in 2011

2008: 52011: 1
2007high 5 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MMP

1in 2025

2010: 12011: 12013: 12014: 12015: 32016: 12018: 12019: 42021: 12022: 12023: 12024: 12025: 1
2007high 4 (2019) · low 0 (2007)2025

MAUDE reports naming product code MMP, 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—00
20080—50
20091—00
20100—01
20110—11
20120—00
20130—01
20140—01
20150—03
20160—01
20170—00
20180—01
20190—04
20200—00
20210—01
20220—01
20230—01
20240—01
20250—01
20260—0—
FIG. 1 — MMP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MMP? 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 878.4370.