510(k) · Cleared
ClearedAYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apyx Medical Corporation · QPB System, Suction, Lipoplasty For Removal
Cleared on Aug 21, 2026 as substantially equivalent to K171286 (Microaire Surgical Instruments, LLC, 2017) after a 91-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Aug 21, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861878 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK861878 Byron Suction TipsByron Medical · 1986
- 3 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- 2 generations backK113795 Suction Lipolasty AccessoriesNorman M. Black Iii · 2012
- 1 generation backK171286 PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017
- This deviceK261710 AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula…Apyx Medical Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| −3 | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| −2 | K113795 | Suction Lipolasty Accessories | Norman M. Black Iii | 2012 | — |
| −1 | K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017 | — |
| 0 (this device) | K261710 | AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors | Apyx Medical Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (1)
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.
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 40 years and passes through 4 companies; a new generation was cleared every 12.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K171286.
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. 2026, 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 AYON™ Power Liposuction Cannulas are indicated for removal of tissue or fluid from the body during
general surgical procedures, including suction lipoplasty, for the purpose of 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/K261710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261710: AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261710
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026