510(k) · Cleared
ClearedLipogems System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lipogems International Spa · MUU System, Suction, Lipoplasty
Cleared on Nov 4, 2016 as substantially equivalent to K142682 (Lipogems International Spa, 2014) after a 143-day review. Its family tree reaches back 9 generations to 1991. 5 later devices descend from it.
- Decided
- Nov 4, 2016
- Review
- 143 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K910696 (1991). 29 ancestors in all, the oldest K861153 (1986). 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 5 generations between
- 3 generations backK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- 2 generations backK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
- 1 generation backK142682 The Lipogems SystemLipogems International Spa · 2014
- This deviceK161636 Lipogems SystemLipogems International Spa · 2016
- Descendant · cites it directly · 2 of its ownK171135 Lipogems SystemLipogems International Spa · 2017
- Descendant · 2 generations on · 1 of its ownK193363 Dermapose RefreshPuregraft, LLC · 2020
- Descendant · cites it directly · 0 of its ownK210528 IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit…Millennium Medical Technologies Inc (Dba Cellmyx) · 2022
- Descendant · 3 generations on · 0 of its ownK202443 Smart Kit Basic, Smart Kit ProBsl Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK182732 JTL-250-01Jointechlabs, Inc. · 2019
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 backK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- 2 generations backK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
- 1 generation backK142682 The Lipogems SystemLipogems International Spa · 2014
- This deviceK161636 Lipogems SystemLipogems International Spa · 2016
Most influential descendants
Showing 5 of 5 · See all- K171135Lipogems SystemLipogems International Spa · 2017 · cites it directly2descendants
- K193363Dermapose RefreshPuregraft, LLC · 2020 · 2 generations on1descendant
- K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx) · 2022 · cites it directly0descendants
- K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd. · 2021 · 3 generations on0descendants
- K182732JTL-250-01Jointechlabs, Inc. · 2019 · cites it directly0descendants
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 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| −2 | K120902 | GID 700 | The Gid Group, Inc. | 2012 | 1 |
| −1 | K142682 | The Lipogems System | Lipogems International Spa | 2014 | — |
| 0 (this device) | K161636 | Lipogems System | Lipogems International Spa | 2016 | — |
| +1 | K171135 | Lipogems System | Lipogems International Spa | 2017 | — |
| +2 | K193363 | Dermapose Refresh | Puregraft, LLC | 2020 | — |
| +1 | K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat… | Millennium Medical Technologies Inc (Dba Cellmyx) | 2022 | — |
| +3 | K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021 | — |
| +1 | K182732 | JTL-250-01 | Jointechlabs, Inc. | 2019 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K142682 | The Lipogems SystemSummary page 4…Plastic Surgery Common Name: Lipoplasty System FDA Classification: Class II Predicate Device: K142682 The Lipogems System, Lipogems International, S.p.A. Reference Device: K150156 Ranfac FATS Procedure Pack,… | 2014 |
| † | K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration… | 2015 |
What descends from it? (5)
3 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 25 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 29 ancestors have a recall of any class.
- Of its descendants, K171135 (Lipogems International Spa, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery…
Read the full statement (120 words)
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161636: Lipogems System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161636
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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