510(k) · Cleared
ClearedLipokit with Disposable 50CC Aft Syringe, Model ZLK-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Khan USA, Inc. · MUU System, Suction, Lipoplasty
Cleared on May 18, 2009 as substantially equivalent to K050797 (Shippert Medical Technologies Corp., 2005) and 2 other predicates after a 178-day review. Its family tree reaches back 6 generations to 1991. 5 later devices descend from it.
- Decided
- May 18, 2009
- Review
- 178 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K910696 (1991). 26 ancestors in all, the oldest K861153 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 5 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 4 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 3 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 2 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 1 generation backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- This deviceK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK101713 Lipcollector IIHuman Med AG · 2010
- Descendant · 2 generations on · 2 of its ownK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
- Descendant · 4 generations on · 0 of its ownK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK121703 Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K101713Lipcollector IIHuman Med AG · 2010 · cites it directly3descendants
- K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012 · 2 generations on2descendants
- K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015 · 3 generations on1descendant
- K171242Alma LipoFlow SystemAlma Lasers, Inc. · 2017 · 4 generations on0descendants
- K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −5 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −4 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −3 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −2 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −1 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| 0 (this device) | K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 | Medi-Khan USA, Inc. | 2009 | — |
| +1 | K101713 | Lipcollector II | Human Med AG | 2010 | — |
| +2 | K120328 | Origins Lipoharvesting System | Sound Surgical Technologies, LLC | 2012 | — |
| +3 | K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | 2015 | — |
| +4 | K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017 | — |
| +1 | K121703 | Lipokit with Disposable 50CC Aft Syringe | Medi-Khan USA, Inc. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K050797 | Tissu-TransSummary page 2…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), Cytori AFT System (K072587) and MacroPore Puricel Lipoplasty System (K042261); Class I and Class II Medical Devices that were c… | 2005 |
| * | K072587 | Cytori Aft SystemSummary page 2…owing predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), Cytori AFT System (K072587) and MacroPore Puricel Lipoplasty System (K042261); Class I and Class II Medical Devices that were cleared for Marketing in the U… | 2007 |
| * | K042261 | Macropore Puricel Lipoplasty SystemSummary page 2…by FDA to be substantially equivalent to premarket devices: Shippert Medical Tissu-Trans (K050797), Cytori AFT System (K072587) and MacroPore Puricel Lipoplasty System (K042261); Class I and Class II Medical Devices that were cleared for Marketing in the United States under K050797, K072587 and K042261 re… | 2004 |
What descends from it? (5)
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 18 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K101713 (Human Med AG, 2010) has gone furthest, with 3 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. 2009, 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 Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and
transferring of autologous fat tissue.
The Lipokit is intended for use in the following surgical specialties when the aspiration of
soft tissue is desired:
Plastic and Reconstructive Surgery
General Surgery
Dermatological Surgery
Obstetrician & Gynecological Surgery
Cosmetic Surgery
The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues
for aesthetic body and facial contouring is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083455 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083455: Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083455
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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