510(k) · Cleared
ClearedPuregraft 50 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 24, 2014 as substantially equivalent to K092923 (Cytori Therapeutics, Inc., 2010) and 1 other predicate after a 137-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Jan 24, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K910696 (1991). 32 ancestors in all, the oldest K861153 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 5 generations between
- 3 generations backK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- 2 generations backK092923 Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010
- 1 generation backK113255 Puregraft 850/Pure SystemCytori Therapeutics, Inc. · 2012
- This deviceK132815 Puregraft 50 SystemCytori Therapeutics, Inc. · 2014
Show all 9 generations
- Root · 9 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 8 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 7 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 6 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 5 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 4 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- 3 generations backK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- 2 generations backK092923 Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010
- 1 generation backK113255 Puregraft 850/Pure SystemCytori Therapeutics, Inc. · 2012
- This deviceK132815 Puregraft 50 SystemCytori Therapeutics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −8 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −7 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −6 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −5 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −4 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| −3 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| −2 | K092923 | Cytori Puregraft 250/Pure System | Cytori Therapeutics, Inc. | 2010 | — |
| −1 | K113255 | Puregraft 850/Pure System | Cytori Therapeutics, Inc. | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K092923 | Cytori Puregraft 250/Pure SystemSummary page 3…les with the following predicate devices which have been determined by FDA to be substantially equivalent to a premarket device: the Cytori Puregraft® 250/PURE System (K092923), and Puregraft 850/PURE System (KI 13255); both are a Class 11 medical device that have been cleared for marketing in the Unite… | 2010 |
| * | K113255 | Puregraft 850/Pure SystemSummary page 3…body contouring. Design and Materials The design and materials of the Puregraft 50 System and the Puregraft 250/PURE System (K092923) and Puregraft 850/PURE System (KI 113255) are substantially equivalent as they are all single-use, polymer constructed, manually operated systems that receive adipose tis… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 32 ancestors have a recall of any class.
- 1 other device also cites its predicate K092923.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Puregraft 50 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/K132815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132815: Puregraft 50 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132815
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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