510(k) · Cleared
ClearedCytori Lipoplasty System with Celase Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytori Therapeutics, Inc. · QPB System, Suction, Lipoplasty For Removal
Cleared on Jan 24, 2007 as substantially equivalent to K042261 (Macropore Biosurgery, Inc., 2004) and 2 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jan 24, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K910696 (1991). 24 ancestors in all, the oldest K771955 (1977). No later device cites it as a predicate yet.
- Root · 5 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 4 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 3 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 2 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 1 generation backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- This deviceK063235 Cytori Lipoplasty System with Celase ReagentCytori Therapeutics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −4 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −3 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −1 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| 0 (this device) | K063235 | Cytori Lipoplasty System with Celase Reagent | Cytori Therapeutics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 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 |
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? (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 |
|---|---|---|---|
| * | K042261 | Macropore Puricel Lipoplasty SystemSummary page 7…n principles with the following predicate device which has been determined by FDA to be substantially equivalent to a pre- amendment device: MacroPore Lipoplasty System (K042261), Flow Laboratories Trypsin (K771955) and Oxoid USA Sputasol (K802493); Class II medical devices that were cleared for marketing… | 2004 |
| * | K771955 | Trypsin 1%Summary page 7…cate device which has been determined by FDA to be substantially equivalent to a pre- amendment device: MacroPore Lipoplasty System (K042261), Flow Laboratories Trypsin (K771955) and Oxoid USA Sputasol (K802493); Class II medical devices that were cleared for marketing in the United States under K042261, K… | 1977 |
| * | K802493 | SputasolSummary page 7…ined by FDA to be substantially equivalent to a pre- amendment device: MacroPore Lipoplasty System (K042261), Flow Laboratories Trypsin (K771955) and Oxoid USA Sputasol (K802493); Class II medical devices that were cleared for marketing in the United States under K042261, K771955, and K802493 respectively.… | 1980 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
- 2 other devices also cite its predicate K042261.
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. 2007, this device’s year, is highlighted.
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 Cytori 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 Cytori Lipoplasty System is indicated for use when the…
Read the full statement (106 words)
The Cytori 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 Cytori Lipoplasty System is indicated for use when the fragmentation, emulsification, and
aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
The Celase Reagent is intended for use in the fragmentation, emulsification, disaggregation, and
liquefaction of soft tissues and subcutaneous fatty tissues within the Lipoplasty System's collection
canister.
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/K063235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063235: Cytori Lipoplasty System with Celase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063235
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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