510(k) · Cleared
ClearedPAL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments, LLC · QPB System, Suction, Lipoplasty For Removal
Cleared on Jun 10, 2022 as substantially equivalent to K053451 (Moeller Medical GmbH & Co. KG, 2006) after a 346-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it.
- Decided
- Jun 10, 2022
- Review
- 346 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K895761 (1989). 10 ancestors in all, the oldest K832274 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK895761 General AsperatorKolster Methods · 1989
- 4 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 3 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 2 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 1 generation backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- This deviceK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
- Descendant · cites it directly · 0 of its ownK251944 Lipocosm Harmonic SystemLipocosm, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253396 AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical Corporation · 2026
- Descendant · cites it directly · 0 of its ownK240188 Vitruvian LiposaberBlack & Black Surgical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −4 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −3 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −2 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −1 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| 0 (this device) | K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022 | — |
| +1 | K251944 | Lipocosm Harmonic System | Lipocosm, LLC | 2026 | — |
| +1 | K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | 2026 | — |
| +1 | K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 K244050 AYON Body Contouring System (AYON SYSTEM)score 13.5 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Summary page 5…General & Plastic Surgery 4. Predicate Device(s) Device name: Vibrasat® Power (console and vibration handpiece for the liposuction cannula) 510(k) number: K053451 Manufacturer: Moeller Medical GMBH & Co. KG. The device of interest for comparison are the Vibrasat® power console and hand… | 2006 |
| † | K973268 | Microaire Power Aspiration Device Pad System | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K251944 (Lipocosm, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K053451.
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. 2022, 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?
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/K212024 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212024: PAL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212024
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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