510(k) · Cleared
ClearedPAL 7020 Console
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 Apr 25, 2025 as substantially equivalent to K161176 (Mentor Worldwide, LLC, 2016) after a 116-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Apr 25, 2025
- Review
- 116 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011500 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- 4 generations backK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
- 3 generations backK142998 CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014
- 2 generations backK150777 Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · Recalled
- 1 generation backK161176 ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC · 2016 · Recalled
- This deviceK244026 PAL 7020 ConsoleMicroaire Surgical Instruments, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| −4 | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | 4 |
| −3 | K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014 | — |
| −2 | K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015 | 2 |
| −1 | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016 | 2 |
| 0 (this device) | K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | 2025 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161176 | ARTOURA Breast Tissue Expanders with Smooth SurfaceSummary page 5…lassified, Pre-Amendment Panel General & Plastic Surgery Product Code LCJ III. PREDICATE DEVICE K161176, Mentor Artoura™ Smooth Breast Tissue Expanders This predicate has not been subjected to a design-related recall.… | 2016 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K161176.
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. 2025, 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 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244026: PAL 7020 Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244026
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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