510(k) Report

510(k) · Cleared

Cleared

Lipisystems Aquavage, Models AV2000 and AV1200

K092284510(k) SpecialCleared Sep 1, 200934-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

Medical Device Resource Corp. · MUU System, Suction, Lipoplasty

Cleared on Sep 1, 2009 as substantially equivalent to K081593 (Medical Device Resource Corp., 2008) after a 34-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it.

Decided
Sep 1, 2009
Review
34 days
Class
Class II
Product code
MUU
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K895761 (1989). 7 ancestors in all, the oldest K832274 (1983). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor1983: 1 other ancestor2017: 2 descendants cleared2015: 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. · 2003K081593 · Power Aspirator, Model LS2 or LS2DP · Medical Device Resource Corp. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant K081593 · Power Aspirator, Model LS2 or LS2DP · Medical Device Resource Corp. · 2008K032802 · 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 · 1989−50
  1. Root · 5 generations backK895761 General AsperatorKolster Methods · 1989
  2. 4 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
  3. 3 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
  4. 2 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
  5. 1 generation backK081593 Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008
  6. This deviceK092284 Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp. · 2009
  7. Descendant · cites it directly · 1 of its ownK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
  8. Descendant · 2 generations on · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
  9. Descendant · cites it directly · 0 of its ownK161372 The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015 · cites it directly1descendant
  • K171242Alma LipoFlow SystemAlma Lasers, Inc. · 2017 · 2 generations on0descendants
  • K161372The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K895761General AsperatorKolster Methods1989—
−4K980392Psi-Tec AspiratorByron Medical1998—
−3K981215Psi-Tec Liposuction AspiratorByron Medical1998—
−2K032802HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc.2003—
−1K081593Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp.2008—
0 (this device)K092284Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp.2009—
+1K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC2015—
+2K171242Alma LipoFlow SystemAlma Lasers, Inc.2017—
+1K161372The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201720
FIG. 1 — Lineage of K092284, 1989–2017Source: 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 MUU? 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 MUU device

  1. #1 K210528 IntelliFat Disposable Adipose Tissue…score 5.7 · 10 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? (1)

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
*K081593Power Aspirator, Model LS2 or LS2DP
Summary page 1
…Suction Lipoplasty System, Class Il - 21 CFR § 878.5040, Product Code: MUU 21 CFR 880.6960 - Syringe, Class I (Sterile), Product Code: KYZ Legally marketed device: K081593 - LS Liposuction Aspirator Description of Device: 1. Contains port interfaces between: Canister to tubing & aspirator to canist…
Medical Device Resource Corp.2008—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151
K161372The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply20170

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 20 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K150779 (Microaire Surgical Instruments, LLC, 2015) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MUU devices

MUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

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. “K092284: Lipisystems Aquavage, Models AV2000 and AV1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092284

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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