510(k) · Cleared
ClearedRanfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranfac, Corp. · MUU System, Suction, Lipoplasty
Cleared on Oct 19, 2015 as substantially equivalent to K121005 (Harvest Technologies, Corp., 2012) after a 269-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Oct 19, 2015
- Review
- 269 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 1
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 deviceK150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac…Ranfac, Corp. · 2015
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 deviceK150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac…Ranfac, Corp. · 2015
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) | K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat… | Ranfac, Corp. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K121005 | Adiprep Adipose Transfer SystemSummary page 4…ion: Class II 3. Predicate Device: Trade Name 510(k) Company Harvest AdiPrep System K121005 Harvest Technologies 4. Device Description The Ranfac Fat Aspirate Transfer System (FATS) is designed to allow f… | 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 24 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.
- 6 other devices also cite its predicate K121005.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Ranfac FATS Procedure Pack is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & 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/K150156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150156: Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150156
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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