510(k) Report

FDA product code · General and plastic surgery

Generator, Electrosurgical, Coagulation, Cancer

MULClass II21 CFR 878.4400510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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 MUL 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 · MUL

FDA has decided no MUL device since 2007.

Median 510(k) review, days · MUL

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

Recalls per year · MUL

No recall names MUL since 2007.

Adverse event reports per year · MUL

1in 2015

2008: 22009: 12012: 202013: 742014: 502015: 1
2007high 74 (2013) · low 0 (2007)2025

MAUDE reports naming product code MUL, 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—02
20090—01
20100—00
20110—00
20120—020
20130—074
20140—050
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MUL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MUL? 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 878.4400.