510(k) Report

FDA product code · General and plastic surgery

System, Suction, Lipoplasty

MUUClass II21 CFR 878.5040510(k) required40 decisions since 20075 recalls

40 FDA decisions since 2007. 510(k) reviews decided 2021–2025 took a median of 197 days (half between 192 and 292). 5 recalls name this code, 0 of them Class I. The most-cited predicate is K121005, named by 7 later devices.

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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 MUU 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 · MUU

1in 2022

2007: 12008: 12009: 32010: 42012: 52013: 12014: 42015: 32016: 12017: 72018: 12019: 42020: 22021: 22022: 1
2007high 7 (2017) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUU

190in 2019

2009: 113 days median2010: 58 days median2012: 171 days median2014: 114 days median2015: 269 days median2017: 91 days median2019: 190 days median
2007high 269 (2015) · low 58 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUU

2in 2017

2007: 12015: 12016: 12017: 2
2007high 2 (2017) · low 0 (2008)2026

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

Adverse event reports per year · MUU

10in 2025

2007: 22008: 42009: 22010: 42011: 52012: 42013: 212014: 132015: 442016: 202017: 282018: 302019: 352020: 362021: 282022: 502023: 152024: 52025: 10
2007high 50 (2022) · low 2 (2007)2025

MAUDE reports naming product code MUU, 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
20071—12
20081—04
2009311302
201045804
20110—05
2012517104
20131—021
20144114013
20153269144
20161—120
2017791228
20181—030
20194190035
20202—036
20212—028
20221—050
20230—015
20240—05
20250—010
20260—0—
FIG. 1 — MUU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MUU? 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 878.5040.