510(k) · Cleared
ClearedCytori Aft System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytori Therapeutics, Inc. · MUU System, Suction, Lipoplasty
Cleared on Dec 10, 2007 as substantially equivalent to K050797 (Shippert Medical Technologies Corp., 2005) and 2 other predicates after an 87-day review. Its family tree reaches back 5 generations to 1991. 34 later devices descend from it.
- Decided
- Dec 10, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K910696 (1991). 25 ancestors in all, the oldest K861153 (1986). 34 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 4 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 3 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 2 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 1 generation backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- This deviceK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- Descendant · cites it directly · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
- Descendant · cites it directly · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · cites it directly17descendants
- K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · cites it directly12descendants
- K120902GID 700The Gid Group, Inc. · 2012 · 2 generations on11descendants
- K100114Fat Concentration SystemBiomet, Inc. · 2010 · cites it directly8descendants
- K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −4 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −3 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −1 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| 0 (this device) | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +1 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| +1 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| +2 | K120902 | GID 700 | The Gid Group, Inc. | 2012 | 1 |
| +1 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| +2 | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 3…sign principles with the following predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), MacroPore Puricel Lipoplasty System (K042261), Exel International Disposable Syringe (K861153) and Genesis Biosystems Lipivage… | 2005 |
| * | K042261 | Macropore Puricel Lipoplasty SystemSummary page 3…vices which have been determined by FDA to be substantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), MacroPore Puricel Lipoplasty System (K042261), Exel International Disposable Syringe (K861153) and Genesis Biosystems Lipivage (5 10(k) number unknown); Class I and 11 medica… | 2004 |
| * | K861153 | Disposable Syringes and Hypodermic NeedlesSummary page 3…stantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), MacroPore Puricel Lipoplasty System (K042261), Exel International Disposable Syringe (K861153) and Genesis Biosystems Lipivage (5 10(k) number unknown); Class I and 11 medical devices that were cleared for marketing in the… | 1986 |
| * | — | Genesis Biosystems Lipivage Named without a submission number |
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | 2009 | 17 |
| K081848 | Lipose Fat Transfer System | 2008 | 12 |
| K100114 | Fat Concentration System | 2010 | 8 |
| K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 | 2009 | 5 |
| K101713 | Lipcollector II | 2010 | 3 |
| K092923 | Cytori Puregraft 250/Pure System | 2010 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K092482 (Shippert Medical Technologies Corp., 2009) has gone furthest, with 17 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. 2007, 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?
Cytori AFT System is used in the aspiration, harvesting, filtering and transfering of autologous tissue. The Cytori AFT System is intended for use in the following surgical specialties when the aspiration of soft 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…
Read the full statement (91 words)
Cytori AFT System is used in the aspiration, harvesting, filtering and transfering of autologous tissue.
The Cytori AFT System is intended for use in the following surgical specialties when the aspiration of soft 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
The Cytori AFT System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072587: Cytori Aft System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072587
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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