510(k) Report

FDA product code · Cardiovascular

Glue, Surgical, Arteries

MUQClass IIIPMA required1 decision since 20012 recalls

1 FDA decision since 2001. 2 recalls name this code, 0 of them Class I.

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, cardiovascular panel

Twenty years of MUQ 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 · MUQ

1in 2025

2007: 32008: 12009: 22010: 12012: 12013: 12015: 12016: 52017: 32018: 32019: 52021: 22022: 12023: 12025: 12026 (partial year): 1
2007high 5 (2016) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUQ

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

Recalls per year · MUQ

2in 2021

2021: 2
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · MUQ

11in 2025

2009: 142010: 502011: 302012: 342013: 472014: 402015: 562016: 282017: 312018: 252019: 392020: 252021: 252022: 122023: 72024: 142025: 11
2007high 56 (2015) · low 0 (2007)2025

MAUDE reports naming product code MUQ, 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
20073—00
20081—00
20092—014
20101—050
20110—030
20121—034
20131—047
20140—040
20151—056
20165—028
20173—031
20183—025
20195—039
20200—025
20212—225
20221—012
20231—07
20240—014
20251—011
20261—0—
FIG. 1 — MUQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MUQ? 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