510(k) · Cleared
ClearedFat Concentration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MUU System, Suction, Lipoplasty
Cleared on Sep 29, 2010 as substantially equivalent to K072587 (Cytori Therapeutics, Inc., 2007) and 1 other predicate after a 257-day review. Its family tree reaches back 7 generations to 1991. 8 later devices descend from it.
- Decided
- Sep 29, 2010
- Review
- 257 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910696 (1991). 30 ancestors in all, the oldest K861153 (1986). 8 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 6 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 5 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 4 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 3 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 2 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- 1 generation backK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- This deviceK100114 Fat Concentration SystemBiomet, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK203800 SyntrFuge SystemSyntr Health Technologies, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK190386 KTA Adipose Treatment KitStemics S.A.S · 2019
- Descendant · 2 generations on · 0 of its ownK172717 Automatic Tissue Processing UnitBsl Co. · 2018
- Descendant · 2 generations on · 0 of its ownK150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac…Ranfac, Corp. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · cites it directly7descendants
- K203800SyntrFuge SystemSyntr Health Technologies, Inc. · 2021 · 2 generations on0descendants
- K190386KTA Adipose Treatment KitStemics S.A.S · 2019 · 2 generations on0descendants
- K172717Automatic Tissue Processing UnitBsl Co. · 2018 · 2 generations on0descendants
- K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −6 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −5 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −4 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −3 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −2 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| −1 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| 0 (this device) | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| +1 | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | 1 |
| +2 | K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021 | — |
| +2 | K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019 | — |
| +2 | K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018 | — |
| +2 | K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat… | Ranfac, Corp. | 2015 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072587 | Cytori Aft SystemSummary page 1…lassification Name: Suction'Lipoplasty System MUU (21 CFR 878.5040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K.072587 Cytori. AFT System-, Cytori Therapeutics, Inc. K08 1848 Lipose F~at 'Transfer System, Lipose Corporation Device… | 2007 |
| * | K081848 | Lipose Fat Transfer SystemSummary page 1…MUU (21 CFR 878.5040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K.072587 Cytori. AFT System-, Cytori Therapeutics, Inc. K08 1848 Lipose F~at 'Transfer System, Lipose Corporation Device Description: The VATS System includes a disposable fat concentrator,… | 2008 |
| * | — | Viafill System Named without a submission number |
What descends from it? (8)
3 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 19 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K121005 (Harvest Technologies, Corp., 2012) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K072587.
How does its category compare?
All MUU devicesMUU 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
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 Vortech Adipose Transfer System (VATS) is used in medical procedures involving the harvesting and transferring of autologous fat tissue. The VATS System is used for concentrating fat harvested with a legally marketed lipoplasty system. The VATS System is intended for use in the following surgical specialties when the concentration of adipose tissue is desired.
* Neurosurgery
* Gastrointestinal and Affiliated Organ Surgery
* Urological Surgery
* Plastic and Reconstructive Surgery
* General Surgery
* Orthopedic Surgery
* Gynecological Surgery
* Thoracic Surgery
* Laparoscopic Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100114: Fat Concentration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100114
Report an extraction error
Are you the manufacturer?
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