510(k) · Cleared
ClearedLipomatic; Lipomatic Liposuction Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euromi S.A · QPB System, Suction, Lipoplasty For Removal
Cleared on Jun 29, 2001 as substantially equivalent to K981922 (Microaire Surgical Instruments, Inc., 1998) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jun 29, 2001
- Review
- 148 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981922 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981922 Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty…Microaire Surgical Instruments, Inc. · 1998
- This deviceK010311 Lipomatic; Lipomatic Liposuction DeviceEuromi S.A · 2001
- Descendant · cites it directly · 0 of its ownK241835 AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx · 2024
Most influential descendants
Showing 1 of 1 · See all- K241835AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981922 | Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic… | Microaire Surgical Instruments, Inc. | 1998 | — |
| 0 (this device) | K010311 | Lipomatic; Lipomatic Liposuction Device | Euromi S.A | 2001 | — |
| +1 | K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K981922 | Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument…Summary page 5…ice |21 CFR 807.92(a)(3)] JUN 2 9 2001 The predicate device is the MicroAire Power Aspiration Device PAD System, which received clearance on 12/10/98 under 510k number K981922 and the Bryon Medical Accelerator Reciprocating Cannula, which received clearance on 8/4/00 under 510k number K001803. Descript… | 1998 |
| * | K001803 | Accelerator Reciprocating CannulaSummary page 5…h received clearance on 12/10/98 under 510k number K981922 and the Bryon Medical Accelerator Reciprocating Cannula, which received clearance on 8/4/00 under 510k number K001803. Description of the Device [21 CFR 807.92(a)(4)] The subject device consists of: . Lipomatichontrol Unit e Tubing e Key for the… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | 2024 | 0 |
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?
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 subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction tipoplasty for 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/K010311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010311: Lipomatic; Lipomatic Liposuction Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010311
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026