510(k) · Cleared
ClearedCytori Puregraft 250/Pure 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 Jan 6, 2010 as substantially equivalent to K072587 (Cytori Therapeutics, Inc., 2007) and 2 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 6, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K910696 (1991). 30 ancestors in all, the oldest K861153 (1986). 2 later devices descend from it, 2 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 deviceK092923 Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK113255 Puregraft 850/Pure SystemCytori Therapeutics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132815 Puregraft 50 SystemCytori Therapeutics, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −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) | K092923 | Cytori Puregraft 250/Pure System | Cytori Therapeutics, Inc. | 2010 | — |
| +1 | K113255 | Puregraft 850/Pure System | Cytori Therapeutics, Inc. | 2012 | — |
| +1 | K132815 | Puregraft 50 System | Cytori Therapeutics, 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 4…rinciples with the following predicate devices which have been determined by FDA to be substantially equivalent to prernarket devices: the Cytori AFT System (K072587), the Sliippert Medical Tissu-Trans (K050797), and the Lipose Fat Transfer System (K08 1848); Class II medical devices that… | 2007 |
| * | K050797 | Tissu-TransSummary page 4…devices which have been determined by FDA to be substantially equivalent to prernarket devices: the Cytori AFT System (K072587), the Sliippert Medical Tissu-Trans (K050797), and the Lipose Fat Transfer System (K08 1848); Class II medical devices that were cleared for marketing in the United Sta… | 2005 |
| * | K081848 | Lipose Fat Transfer SystemSummary page 4…tantially equivalent to prernarket devices: the Cytori AFT System (K072587), the Sliippert Medical Tissu-Trans (K050797), and the Lipose Fat Transfer System (K08 1848); Class II medical devices that were cleared for marketing in the United States under K072587, 1K050797, and K08 1848 respe… | 2008 |
What descends from it? (2)
2 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 6 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, K113255 (Cytori Therapeutics, Inc., 2012) has gone furthest, with 1 descendant 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 Cytori PureGraft 250/PUR-E System is indicated for use in the harvesting filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092923: Cytori Puregraft 250/Pure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092923
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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