510(k) Report

FDA product code · General and plastic surgery

Lipoaspirate Washing System For Aesthetic Body Contouring

QKLClass II21 CFR 878.5040510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation

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 QKL 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 · QKL

FDA has decided no QKL device since 2007.

Median 510(k) review, days · QKL

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

Recalls per year · QKL

No recall names QKL since 2007.

Adverse event reports per year · QKL

28in 2025

2023: 182024: 252025: 28
2007high 28 (2025) · low 0 (2007)2025

MAUDE reports naming product code QKL, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—018
20240—025
20250—028
20260—0—
FIG. 1 — QKL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QKL? 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.