510(k) Report

510(k) · Cleared

Cleared

Lipcollector II

K101713510(k) TraditionalCleared Jun 29, 201011-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

Human Med AG · MUU System, Suction, Lipoplasty

Cleared on Jun 29, 2010 as substantially equivalent to K072587 (Cytori Therapeutics, Inc., 2007) and 1 other predicate after an 11-day review. Its family tree reaches back 7 generations to 1991. 3 later devices descend from it.

Decided
Jun 29, 2010
Review
11 days
Class
Class II
Product code
MUU
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K910696 (1991). 27 ancestors in all, the oldest K861153 (1986). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1986: 2 other ancestors1998: 3 other ancestors1988: 2 other ancestors2001: 1 other ancestor1999: 3 other ancestors1997: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor2012: 1 descendant cleared2015: 1 descendant cleared2017: 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. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 4 other ancestors5 generations back: 8 other ancestors6 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K083455 · Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 · Medi-Khan USA, Inc. · 2009K072587 · Cytori Aft System · Cytori Therapeutics, Inc. · 2007K042261 · Macropore Puricel Lipoplasty System · Macropore Biosurgery, Inc. · 2004K022051 · Soundvaser System · Sound Surgical Technologies, LLC · 2002 · recalledK983065 · Mentor Ultrasound-Assisted Tissue Removal System · Mentor Corp. · 1998K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991−50
  1. Root · 7 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 6 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. 5 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
  4. 4 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. 3 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
  6. 2 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
  7. 1 generation backK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
  8. This deviceK101713 Lipcollector IIHuman Med AG · 2010
  9. Descendant · cites it directly · 2 of its ownK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
  10. Descendant · 2 generations on · 1 of its ownK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
  11. Descendant · 3 generations on · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012 · cites it directly2descendants
  • K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015 · 2 generations on1descendant
  • K171242Alma LipoFlow SystemAlma Lasers, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198820
199210
199410
199520
199620
199720
199830
199930
200110
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201710
FIG. 1 — Lineage of K101713, 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? (3)

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
*K072587Cytori Aft System
Summary page 1
…ring of autologous fat tissue. 3. Name of predicate device(s) * Cytori AFT System; Cytori TherapeuticslInc - Product Code MUU; 510(k) number K072587 a Lipokit; Medi-Khan (USA) Inc - Product Code MUU; 510(k) number K083455 * Lipivage; Genesis Biosystems, inc.…
Cytori Therapeutics, Inc.2007—
*K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100
Summary page 1
…tori AFT System; Cytori TherapeuticslInc - Product Code MUU; 510(k) number K072587 a Lipokit; Medi-Khan (USA) Inc - Product Code MUU; 510(k) number K083455 * Lipivage; Genesis Biosystems, inc. - 510(k) number unknown…
Medi-Khan USA, Inc.2009—
*—Genesis Biosystems Lipivage
Named without a submission number
—

Also cleared against K072587: 5 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122

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 19 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
  • 4 of the 27 ancestors have a recall of any class.
  • Of its descendants, K120328 (Sound Surgical Technologies, LLC, 2012) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate K072587.

How does its category compare?

All MUU devices

MUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

Aesthetic body contouring

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K101713: Lipcollector II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101713

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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