510(k) · Cleared
ClearedSmart Kit Basic, Smart Kit Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bsl Co., Ltd. · MUU System, Suction, Lipoplasty
Cleared on Mar 11, 2021 as substantially equivalent to K193363 (Puregraft, LLC, 2020) after a 197-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Mar 11, 2021
- Review
- 197 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910696 (1991). 32 ancestors in all, the oldest K861153 (1986). No later device cites it as a predicate yet.
- Root · 12 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 8 generations between
- 3 generations backK161636 Lipogems SystemLipogems International Spa · 2016
- 2 generations backK171135 Lipogems SystemLipogems International Spa · 2017
- 1 generation backK193363 Dermapose RefreshPuregraft, LLC · 2020
- This deviceK202443 Smart Kit Basic, Smart Kit ProBsl Co., Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 11 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 10 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 9 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 8 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 7 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- 6 generations backK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- 5 generations backK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
- 4 generations backK142682 The Lipogems SystemLipogems International Spa · 2014
- 3 generations backK161636 Lipogems SystemLipogems International Spa · 2016
- 2 generations backK171135 Lipogems SystemLipogems International Spa · 2017
- 1 generation backK193363 Dermapose RefreshPuregraft, LLC · 2020
- This deviceK202443 Smart Kit Basic, Smart Kit ProBsl Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −11 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −10 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −9 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −8 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −7 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| −6 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| −5 | K120902 | GID 700 | The Gid Group, Inc. | 2012 | 1 |
| −4 | K142682 | The Lipogems System | Lipogems International Spa | 2014 | — |
| −3 | K161636 | Lipogems System | Lipogems International Spa | 2016 | — |
| −2 | K171135 | Lipogems System | Lipogems International Spa | 2017 | — |
| −1 | K193363 | Dermapose Refresh | Puregraft, LLC | 2020 | — |
| 0 (this device) | K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K193363 | Dermapose RefreshSummary page 4…rt 878.5040 Regulation Name: General & Plastic Surgery Regulatory Class: Class II Product Code: MUU Predicate Device: Dermapose Refresh (K193363, clearance received April 14,2020)… | 2020 |
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 30 years and passes through 10 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 32 ancestors have a recall of any class.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Smart Kit is disposable and is indicated for autologous fat transfer. The autologous fat transfer is also technically called as autologous fat grafting or reinjection of concentrated adipose-tissue into the recipient body areas. The Smart kit can be used for concentration and transfer of homogenous adipose tissues with legally marketed lipoplasty system when the concentrated and homogenous fat tissue is re-injected into the recipient body areas of…
Read the full statement (130 words)
The Smart Kit is disposable and is indicated for autologous fat transfer. The autologous fat transfer is also technically called as autologous fat grafting or reinjection of concentrated adipose-tissue into the recipient body areas. The Smart kit can be used for concentration and transfer of homogenous adipose tissues with legally marketed lipoplasty system when the concentrated and homogenous fat tissue is re-injected into the recipient body areas of the same patient autologously.
This device is intended for autologous fat transfer. The Smart Kit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
Neurosurgery / Gastrointestinal Surgery / Urological Surgery / General surgery / Orthopedic Surgery / Gynecological Surgery /Thoracic Surgery / Laparoscopic Surgery / Arthroscopic Surgery / Plastic and reconstructive surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202443: Smart Kit Basic, Smart Kit Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202443
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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