510(k) · Cleared
ClearedMacropore Puricel Lipoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · QPB System, Suction, Lipoplasty For Removal
Cleared on Sep 20, 2004 as substantially equivalent to K981172 (Byron Medical, 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1991. 36 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910696 (1991). 21 ancestors in all, the oldest K861878 (1986). 36 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 3 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 2 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 1 generation backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- This deviceK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · cites it directly · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · 2 generations on · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- Descendant · 2 generations on · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · cites it directly34descendants
- K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · 2 generations on17descendants
- K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · 2 generations on12descendants
- K120902GID 700The Gid Group, Inc. · 2012 · 3 generations on11descendants
- K100114Fat Concentration SystemBiomet, Inc. · 2010 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −3 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −2 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −1 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| 0 (this device) | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +1 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +2 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| +2 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| +3 | K120902 | GID 700 | The Gid Group, Inc. | 2012 | 1 |
| +2 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 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 |
|---|---|---|---|
| * | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesSummary page 7…ion and Tumescent Infusion Cannulae and Needles and Sound Surgical Soundvaser System, Class II medical devices that were cleared for marketing in the United States under K981172 and K022051 respectively. Indications For Use The MacroPore Puricel Lipoplasty System and the predicate devices share substantia… | 1998 |
| * | K022051 | Soundvaser SystemSummary page 7…scent Infusion Cannulae and Needles and Sound Surgical Soundvaser System, Class II medical devices that were cleared for marketing in the United States under K981172 and K022051 respectively. Indications For Use The MacroPore Puricel Lipoplasty System and the predicate devices share substantially equivale… | 2002 |
What descends from it? (36)
See all 363 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 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K072587 (Cytori Therapeutics, Inc., 2007) has gone furthest, with 34 descendants of its own.
- 7 other devices also cite its predicate K981172.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042261: Macropore Puricel Lipoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042261
Report an extraction error
Are you the manufacturer?
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