510(k) Report

510(k) · Cleared

Cleared

Airbrush Liposculptor System

K031881510(k) TraditionalCleared Jul 28, 200340-day reviewClass II21 CFR 878.5040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosculpture Technology, Inc. · QPB System, Suction, Lipoplasty For Removal

Cleared on Jul 28, 2003 after a 40-day review. The FDA summary names no predicate by number.

Decided
Jul 28, 2003
Review
40 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K031881Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QPB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QPB device

  1. #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All QPB devices

QPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QPB

5so far in 2026, the most since 2007

2007: 22008: 42009: 12010: 22011: 22012: 32014: 12015: 12016: 12017: 32019: 22020: 22022: 22024: 42025: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPB

194in 2024

2008: 69 days median2012: 234 days median2017: 112 days median2024: 194 days median2026 (partial year): 238 days median
2007high 238 (2026) · low 69 (2008)2026

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

Recalls per year · QPB

No recall names QPB since 2007.

Adverse event reports per year · QPB

16in 2025

2022: 52023: 282024: 162025: 16
2007high 28 (2023) · low 0 (2007)2025

MAUDE reports naming product code QPB, 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
20072—00
200846900
20091—00
20102—00
20112—00
2012323400
20130—00
20141—00
20151—00
20161—00
2017311200
20180—00
20192—00
20202—00
20210—00
20222—05
20230—028
20244194016
20252—016
202652380—

What is it indicated for?

The Airbrush T'Liposculptor System is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K031881: Airbrush Liposculptor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031881

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026