510(k) · Cleared
ClearedOrigins Lipoharvesting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sound Surgical Technologies, LLC · MUU System, Suction, Lipoplasty
Cleared on Sep 17, 2012 as substantially equivalent to K092482 (Shippert Medical Technologies Corp., 2009) and 1 other predicate after a 228-day review. Its family tree reaches back 8 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 17, 2012
- Review
- 228 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K910696 (1991). 29 ancestors in all, the oldest K861153 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 7 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 6 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 5 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 4 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 3 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- 2 generations backK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
- 1 generation backK101713 Lipcollector IIHuman Med AG · 2010
- This deviceK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
- Descendant · cites it directly · 1 of its ownK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −7 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −6 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −5 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −4 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −3 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| −2 | K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 | Medi-Khan USA, Inc. | 2009 | — |
| −1 | K101713 | Lipcollector II | Human Med AG | 2010 | — |
| 0 (this device) | K120328 | Origins Lipoharvesting System | Sound Surgical Technologies, LLC | 2012 | — |
| +1 | K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | 2015 | — |
| +2 | K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
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 K210528 IntelliFat Disposable Adipose Tissue…score 5.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Summary page 1…PredicateSi10(k) PredicateManufacturer Equivalent Devices: Number and Model Origins K092482 Shippert Medical LipoHarvesting Technologies / Tissu Trans… | 2009 |
| * | K101713 | Lipcollector IISummary page 1…Technologies / Tissu Trans System Filtron K101713 human med AG/ LipoCallector 11 Complete… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | 2015 | 1 |
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 21 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K150779 (Microaire Surgical Instruments, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K092482.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MUU
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MUU
190in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUU
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUU
10in 2025
MAUDE reports naming product code MUU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 2 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 3 | 113 | 0 | 2 |
| 2010 | 4 | 58 | 0 | 4 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 5 | 171 | 0 | 4 |
| 2013 | 1 | — | 0 | 21 |
| 2014 | 4 | 114 | 0 | 13 |
| 2015 | 3 | 269 | 1 | 44 |
| 2016 | 1 | — | 1 | 20 |
| 2017 | 7 | 91 | 2 | 28 |
| 2018 | 1 | — | 0 | 30 |
| 2019 | 4 | 190 | 0 | 35 |
| 2020 | 2 | — | 0 | 36 |
| 2021 | 2 | — | 0 | 28 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be re-implanted, the harvested flat is only to be used without any additional manipulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120328: Origins Lipoharvesting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120328
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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