510(k) · Cleared
ClearedLysonix Suction Lipoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lysonix, Inc. · QPB System, Suction, Lipoplasty For Removal
Cleared on Jul 13, 1998 after a 136-day review. The FDA summary names no predicate by number. 19 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 136 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK980771 Lysonix Suction Lipoplasty SystemLysonix, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK990602 Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999
- Descendant · 2 generations on · 17 of its ownK060089 Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- Descendant · 4 generations on · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010
- Descendant · 4 generations on · 7 of its ownK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K990602Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999 · cites it directly18descendants
- K060089Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006 · 2 generations on17descendants
- K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · 3 generations on12descendants
- K100114Fat Concentration SystemBiomet, Inc. · 2010 · 4 generations on8descendants
- K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980771 | Lysonix Suction Lipoplasty System | Lysonix, Inc. | 1998 | — |
| +1 | K990602 | Richter Lipoplasty Cannulas and Accessories | Tecsa Technical Services | 1999 | — |
| +2 | K060089 | Tulip Disposable Cannulas | Cell Bio-Systems, Inc. | 2006 | — |
| +3 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| +4 | K100114 | Fat Concentration System | Biomet, Inc. | 2010 | — |
| +4 | K121005 | Adiprep Adipose Transfer System | Harvest Technologies, Corp. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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?
The FDA summary names no predicate by number.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990602 | Richter Lipoplasty Cannulas and Accessories | 1999 | 18 |
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?
- Of its descendants, K990602 (Tecsa Technical Services, 1999) has gone furthest, with 18 descendants of its own.
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 LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
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/K980771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980771: Lysonix Suction Lipoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980771
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