510(k) · Cleared
ClearedLipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · QPB System, Suction, Lipoplasty For Removal
Cleared on Jun 30, 1998 as substantially equivalent to K861878 (Byron Medical, 1986) after a 90-day review. Its family tree reaches back 1 generation to 1986. 65 later devices descend from it.
- Decided
- Jun 30, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861878 (1986). 65 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK861878 Byron Suction TipsByron Medical · 1986
- This deviceK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- Descendant · cites it directly · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 2 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK990602 Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999
- Descendant · 3 generations on · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- Descendant · cites it directly · 17 of its ownK060089 Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · cites it directly36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 2 generations on34descendants
- K990602Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999 · cites it directly18descendants
- K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · 3 generations on17descendants
- K060089Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| 0 (this device) | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| +1 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +2 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +1 | K990602 | Richter Lipoplasty Cannulas and Accessories | Tecsa Technical Services | 1999 | — |
| +3 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| +1 | K060089 | Tulip Disposable Cannulas | Cell Bio-Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 10 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K861878 | Byron Suction TipsSummary page 6…are substantially equivalent to the following commercially distributed devices: Product: Suction Cannulae and Needles Manufacturer: Byron Medical, Inc. 510(k) Number: K861878 Substantial Equivalence Date: 01 July 1986 Substantial Equivalence Letter is presented in Exhibit M. Product: Infusion Cannulae… | 1986 |
| * | — | Infusion Cannulae and Needles Named without a submission number |
What descends from it? (65)
See all 658 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042261 | Macropore Puricel Lipoplasty System | 2004 | 36 |
| K990602 | Richter Lipoplasty Cannulas and Accessories | 1999 | 18 |
| K060089 | Tulip Disposable Cannulas | 2006 | 17 |
| K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252… | 2006 | 13 |
| K113795 | Suction Lipolasty Accessories | 2012 | 5 |
| K092066 | Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste… | 2010 | 2 |
| K082025 | Body-Jet | 2008 | 0 |
| K992282 | Micro-France Liposuction Cannulas | 1999 | 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 Aspiration and Infusion Cannulae and Needles indications for use are 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/K981172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981172: Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981172
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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