510(k) · Cleared
ClearedLipose Fat Transfer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lipose Corp. · MUU System, Suction, Lipoplasty
Cleared on Dec 4, 2008 as substantially equivalent to K050797 (Shippert Medical Technologies Corp., 2005) and 2 other predicates after a 157-day review. Its family tree reaches back 6 generations to 1991. 12 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 157 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K910696 (1991). 29 ancestors in all, the oldest K861153 (1986). 12 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 5 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 4 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 3 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 2 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 1 generation backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- This deviceK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- Descendant · cites it directly · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK092923 Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK113255 Puregraft 850/Pure SystemCytori Therapeutics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK203800 SyntrFuge SystemSyntr Health Technologies, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100114Fat Concentration SystemBiomet, Inc. · 2010 · cites it directly8descendants
- K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · cites it directly7descendants
- K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010 · cites it directly2descendants
- K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc. · 2012 · 2 generations on1descendant
- K203800SyntrFuge SystemSyntr Health Technologies, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −5 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −4 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −3 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −2 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −1 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| 0 (this device) | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| +1 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| +1 | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | 1 |
| +1 | K092923 | Cytori Puregraft 250/Pure System | Cytori Therapeutics, Inc. | 2010 | — |
| +2 | K113255 | Puregraft 850/Pure System | Cytori Therapeutics, Inc. | 2012 | — |
| +2 | K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021 | — |
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 | 4 | 0 |
| 1999 | 4 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050797 | Tissu-TransSummary page 1…valent Device: The subject device is substantially equivalent in intended use/technological characteristics and/or method of operation to: *Tissu-TranS TM Syringe (K050797) *Tulip Disposable Cannulas (K060089) *Cytori AFT System (K072587) *Genesis Biosystems, LipivageTm Fat Harvest, Wa… | 2005 |
| * | K060089 | Tulip Disposable CannulasSummary page 1…antially equivalent in intended use/technological characteristics and/or method of operation to: *Tissu-TranS TM Syringe (K050797) *Tulip Disposable Cannulas (K060089) *Cytori AFT System (K072587) *Genesis Biosystems, LipivageTm Fat Harvest, Wash and Transfer System (K# unknown)… | 2006 |
| * | K072587 | Cytori Aft SystemSummary page 1…e/technological characteristics and/or method of operation to: *Tissu-TranS TM Syringe (K050797) *Tulip Disposable Cannulas (K060089) *Cytori AFT System (K072587) *Genesis Biosystems, LipivageTm Fat Harvest, Wash and Transfer System (K# unknown) Lipose Fat Transf… | 2007 |
| * | — | Genesis Biosystems, LipivageTm Fat Harvest, Wash and Transfer System Named without a submission number |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K100114 (Biomet, Inc., 2010) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K050797.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Lipose Fat Transfer System is intended to be used in the aspiration, harvesting,
filtering ahd reinjecting of autologous fat.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081848: Lipose Fat Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081848
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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