510(k) Report

510(k) · Cleared

Cleared

LipoFilter - Hospital Pack, LipoFilter - Clinic Pack

K150779510(k) TraditionalCleared May 22, 201558-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

Microaire Surgical Instruments, LLC · MUU System, Suction, Lipoplasty

Cleared on May 22, 2015 as substantially equivalent to K120328 (Sound Surgical Technologies, LLC, 2012) and 1 other predicate after a 58-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.

Decided
May 22, 2015
Review
58 days
Class
Class II
Product code
MUU
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K910696 (1991). 38 ancestors in all, the oldest K832274 (1983). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 2 other ancestors2008: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1998: 5 other ancestors1986: 3 other ancestors1989: 1 other ancestor1988: 2 other ancestors1983: 1 other ancestor2001: 1 other ancestor1999: 3 other ancestors1997: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor2017: 1 descendant clearedK910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K983065 · Mentor Ultrasound-Assisted Tissue Removal System · Mentor Corp. · 1998K022051 · Soundvaser System · Sound Surgical Technologies, LLC · 2002 · recalledK042261 · Macropore Puricel Lipoplasty System · Macropore Biosurgery, Inc. · 2004K072587 · Cytori Aft System · Cytori Therapeutics, Inc. · 2007K083455 · Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 · Medi-Khan USA, Inc. · 2009K101713 · Lipcollector II · Human Med AG · 2010K120328 · Origins Lipoharvesting System · Sound Surgical Technologies, LLC · 201219801990200020102020
  1. Root · 9 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 5 generations between
  3. 3 generations backK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
  4. 2 generations backK101713 Lipcollector IIHuman Med AG · 2010
  5. 1 generation backK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
  6. This deviceK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
  7. Descendant · cites it directly · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
Show all 9 generations
  1. Root · 9 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 8 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. 7 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
  4. 6 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. 5 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
  6. 4 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
  7. 3 generations backK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
  8. 2 generations backK101713 Lipcollector IIHuman Med AG · 2010
  9. 1 generation backK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
  10. This deviceK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K171242Alma LipoFlow SystemAlma Lasers, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K910696Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc.1991—
−8K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.1997—
−7K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp.1998—
−6K022051Soundvaser SystemSound Surgical Technologies, LLC20022
−5K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.2004—
−4K072587Cytori Aft SystemCytori Therapeutics, Inc.2007—
−3K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.2009—
−2K101713Lipcollector IIHuman Med AG2010—
−1K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC2012—
0 (this device)K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC2015—
+1K171242Alma LipoFlow SystemAlma Lasers, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198630
198820
198910
199210
199410
199520
199620
199720
199850
199930
200110
200310
200510
200810
200920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K150779, 1991–2017Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K120328Origins Lipoharvesting System
Summary page 4
…em Classification: Suction lipoplasty system (21 CFR 878.5040, Product Code MUU) 5) Predicate Device: Sound Surgical Technologies – Origins LipoHarvesting System (K120328) Medical Device Resource Corporation – Lipisystems Aquavage Model AV2000 & 1200 (K092284) 6) Device Description: The Micro…
Sound Surgical Technologies, LLC2012—
*K092284Lipisystems Aquavage, Models AV2000 and AV1200
Summary page 4
…te Device: Sound Surgical Technologies – Origins LipoHarvesting System (K120328) Medical Device Resource Corporation – Lipisystems Aquavage Model AV2000 & 1200 (K092284) 6) Device Description: The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system compri…
Medical Device Resource Corp.2009—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171242Alma LipoFlow SystemAlma Lasers, Inc.20170

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 24 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
  • 5 of the 38 ancestors have a recall of any class.
  • Of its descendants, K171242 (Alma Lasers, Inc., 2017) has gone furthest, with 0 descendants 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. 2015, 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?

The MicroAire LipoFilter System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K150779: LipoFilter - Hospital Pack, LipoFilter - Clinic Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150779

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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