510(k) Report

510(k) · Cleared

Cleared

Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V);

K053451510(k) TraditionalCleared Aug 25, 2006256-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

Moeller Medical GmbH & Co. KG · QPB System, Suction, Lipoplasty For Removal

Cleared on Aug 25, 2006 as substantially equivalent to K032802 (Hk Surgical, Inc., 2003) and 3 other predicates after a 256-day review. Its family tree reaches back 4 generations to 1989. 13 later devices descend from it.

Decided
Aug 25, 2006
Review
256 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K895761 (1989). 9 ancestors in all, the oldest K832274 (1983). 13 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors1986: 1 other ancestor1983: 1 other ancestor2007: 1 descendant cleared2008: 2 descendants cleared2022: 2 descendants cleared2026: 3 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2024: 1 descendant clearedK895761 · General Asperator · Kolster Methods · 1989×2: 2 generations cleared close together, K980392 (1998), K981215 (1998) K032802 · HK Liposuction Aspirator, Model AP-Iii & AP230-Iii · Hk Surgical, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants K032802 · HK Liposuction Aspirator, Model AP-Iii & AP230-Iii · Hk Surgical, Inc. · 2003K981215 · Psi-Tec Liposuction Aspirator · Byron Medical · 1998K980392 · Psi-Tec Aspirator · Byron Medical · 1998K895761 · General Asperator · Kolster Methods · 19890
  1. Root · 4 generations backK895761 General AsperatorKolster Methods · 1989
  2. 3 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
  3. 2 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
  4. 1 generation backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
  5. This deviceK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
  6. Descendant · cites it directly · 4 of its ownK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
  7. Descendant · cites it directly · 3 of its ownK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
  8. Descendant · 2 generations on · 2 of its ownK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
  9. Descendant · cites it directly · 2 of its ownK072793 Liposat Basic (Infiltration Pump), Model 92-007 688Moeller Medical GmbH & Co. KG · 2008
  10. Descendant · 2 generations on · 1 of its ownK170629 Vitruvian Infiltration PumpBlack & Black Surgical, Inc. · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22015: 12017: 32022: 22024: 12026: 3
2007high 3 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007 · cites it directly4descendants
  • K212024PAL SystemMicroaire Surgical Instruments, LLC · 2022 · cites it directly3descendants
  • K150134Basic, Dominant Flex, KV-6Medela AG · 2015 · 2 generations on2descendants
  • K072793Liposat Basic (Infiltration Pump), Model 92-007 688Moeller Medical GmbH & Co. KG · 2008 · cites it directly2descendants
  • K170629Vitruvian Infiltration PumpBlack & Black Surgical, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K895761General AsperatorKolster Methods1989—
−3K980392Psi-Tec AspiratorByron Medical1998—
−2K981215Psi-Tec Liposuction AspiratorByron Medical1998—
−1K032802HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc.2003—
0 (this device)K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model…Moeller Medical GmbH & Co. KG2006—
+1K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG2007—
+1K212024PAL SystemMicroaire Surgical Instruments, LLC2022—
+2K150134Basic, Dominant Flex, KV-6Medela AG2015—
+1K072793Liposat Basic (Infiltration Pump), Model 92-007 688Moeller Medical GmbH & Co. KG2008—
+2K170629Vitruvian Infiltration PumpBlack & Black Surgical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198610
199820
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201510
201730
202220
202410
202630
FIG. 1 — Lineage of K053451, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032802HK Liposuction Aspirator, Model AP-Iii & AP230-Iii
Summary page 6
…quivalent to the aspiration devices listed below in terms of intended use, design, operating principles, and materials. IIK Surgical, Inc.: K032802 Byron Medical, Inc.: K981172, K001803 MicroAire Surgical Instruments: K981922 6. Device De…
Hk Surgical, Inc.2003—
*K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles
Summary page 6
…w in terms of intended use, design, operating principles, and materials. IIK Surgical, Inc.: K032802 Byron Medical, Inc.: K981172, K001803 MicroAire Surgical Instruments: K981922 6. Device Description: The Moller Medical Lipoplasty Syste…
Byron Medical1998—
*K001803Accelerator Reciprocating Cannula
Summary page 6
…s of intended use, design, operating principles, and materials. IIK Surgical, Inc.: K032802 Byron Medical, Inc.: K981172, K001803 MicroAire Surgical Instruments: K981922 6. Device Description: The Moller Medical Lipoplasty System is an e…
Byron Medical2000—
*K981922Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument…
Summary page 6
…materials. IIK Surgical, Inc.: K032802 Byron Medical, Inc.: K981172, K001803 MicroAire Surgical Instruments: K981922 6. Device Description: The Moller Medical Lipoplasty System is an electrically powered infiltration/peristalitic pump…
Microaire Surgical Instruments, Inc.1998—

Also cleared against K032802: 3 other devices →

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG20074
K212024PAL SystemMicroaire Surgical Instruments, LLC20223
K072793Liposat Basic (Infiltration Pump), Model 92-007 688Moeller Medical GmbH & Co. KG20082
K254135LipoSurg ARTISTNouvag AG20260
K082025Body-JetHuman Med AG20080

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.

What does this lineage say?

  • The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K063336 (Medela AG, 2007) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K032802.

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?

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. “K053451: Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053451

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