510(k) · Cleared
ClearedSmartgraft 30 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingeneron, Inc. · MUU System, Suction, Lipoplasty
Cleared on Sep 24, 2014 as substantially equivalent to K100114 (Biomet, Inc., 2010) and 1 other predicate after a 103-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Sep 24, 2014
- Review
- 103 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 backK100114 Fat Concentration SystemBiomet, Inc. · 2010
- 1 generation backK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
- This deviceK141591 Smartgraft 30 SystemIngeneron, 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 backK100114 Fat Concentration SystemBiomet, Inc. · 2010
- 1 generation backK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
- This deviceK141591 Smartgraft 30 SystemIngeneron, 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 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| −1 | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | 1 |
| 0 (this device) | K141591 | Smartgraft 30 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 |
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 |
|---|---|---|---|
| * | K100114 | Fat Concentration SystemSummary page 4…gulation: 21 CFR 878.5040, Suction Lipoplasty System Product Code: MUU Legally Marketed Devices To Which Substantial Equivalence is Claimed: K100114 Vortech™ Adipose Transfer System, Biomet Biologics, Inc. and, K121005 AdiPrep™… | 2010 |
| * | K121005 | Adiprep Adipose Transfer SystemSummary page 4…ces To Which Substantial Equivalence is Claimed: K100114 Vortech™ Adipose Transfer System, Biomet Biologics, Inc. and, K121005 AdiPrep™ Adipose Transfer System from Harvest Technologies Corp. Device Description: The SmartGraf… | 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 9 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 32 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100114.
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 SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system. The SmartGraft™ 30 system is intended for use in the following surgical specialties when the concentration of harvested…
Read the full statement (102 words)
The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting,
centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 30 system is used for
concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested
with a legally marketed lipoplasty system.
The SmartGraft™ 30 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/K141591 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141591: Smartgraft 30 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141591
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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