510(k) · Cleared
Recalled · Class II · 2016Adiprep Adipose Transfer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvest Technologies, Corp. · MUU System, Suction, Lipoplasty
Cleared on Sep 21, 2012 as substantially equivalent to K081848 (Lipose Corp., 2008) and 1 other predicate after a 171-day review. Its family tree reaches back 8 generations to 1991. 7 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2012
- Review
- 171 days
- Class
- Class II
- Product code
- MUU
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K910696 (1991). 31 ancestors in all, the oldest K861153 (1986). 7 later devices descend from it, 7 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 backK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- 1 generation backK100114 Fat Concentration SystemBiomet, Inc. · 2010
- This deviceK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012
- Descendant · cites it directly · 0 of its ownK203800 SyntrFuge SystemSyntr Health Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK190386 KTA Adipose Treatment KitStemics S.A.S · 2019
- Descendant · cites it directly · 0 of its ownK172717 Automatic Tissue Processing UnitBsl Co. · 2018
- Descendant · cites it directly · 0 of its ownK150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac…Ranfac, Corp. · 2015
- Descendant · cites it directly · 0 of its ownK141713 Smartgraft 200 SystemIngeneron, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203800SyntrFuge SystemSyntr Health Technologies, Inc. · 2021 · cites it directly0descendants
- K190386KTA Adipose Treatment KitStemics S.A.S · 2019 · cites it directly0descendants
- K172717Automatic Tissue Processing UnitBsl Co. · 2018 · cites it directly0descendants
- K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp. · 2015 · cites it directly0descendants
- K141713Smartgraft 200 SystemIngeneron, Inc. · 2014 · cites it directly0descendants
View 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 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| −1 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| 0 (this device) | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | — |
| +1 | K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021 | — |
| +1 | K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019 | — |
| +1 | K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018 | — |
| +1 | K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat… | Ranfac, Corp. | 2015 | — |
| +1 | K141713 | Smartgraft 200 System | Ingeneron, Inc. | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K081848 | Lipose Fat Transfer SystemSummary page 1…(21 CFR 878.5040, Suction Lipoplasty System, Product Code MUU) Legally Marketed Devices to Which Substantial Equivalence Is Claimed: K081848, Viafill System, Lipose Corporation and, KiCOl 14, Vortech Adipose Transfer System, Biomet Biologics,… | 2008 |
| * | K100114 | Fat Concentration SystemSummary page 3…Fat Transfer System, Biomet Vortech Tm Adipose Transfer System K081 848, (Predicate device) System (VATS), 1(100114, (Predicate __________(This submission) _____________ device) Indications for… | 2010 |
What descends from it? (7)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203800 | SyntrFuge System | 2021 | 0 |
| K190386 | KTA Adipose Treatment Kit | 2019 | 0 |
| K172717 | Automatic Tissue Processing Unit | 2018 | 0 |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration… | 2015 | 0 |
| K141713 | Smartgraft 200 System | 2014 | 0 |
| K141591 | Smartgraft 30 System | 2014 | 0 |
| K130152 | Hydrasolve Lipoplasty System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2016 | Class II | Z-0674-2017 | Error in labeling | Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K203800 (Syntr Health Technologies, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K081848.
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 AdiPrepTM Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The AdiPrepTM Adipose Transfer System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
* Neurosurgery
* Gastrointestinal Surgery
* Urological Surgery
* Plastic and Reconstructive Surgery
* General surgery
* Orthopedic Surgery
* Gynecological Surgery
* Thoracic Surgery
* Laparoscopic Surgery
* Arthroscopic Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121005 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121005: Adiprep Adipose Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121005
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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