# K244026: PAL 7020 Console

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments, LLC
- Decided: Apr 25, 2025 after 116 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011500 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface, Mentor Worldwide, LLC (2016) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K244026
Methodology: https://510kreport.com/methodology