# K220318: PAL Infiltration System

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments, LLC
- Decided: Oct 14, 2022 after 253 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: 7 generations back to K895761 (1989). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170629: Vitruvian Infiltration Pump, Black & Black Surgical, Inc. (2017) Summary page 4.
- K113795: Suction Lipolasty Accessories, Norman M. Black Iii (2012) Summary page 5.
- (no number) Single Spike 15’ Large Bore Tubing: named in the summary without a submission number

## Indications for use
The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.

Source page: https://510kreport.com/device/K220318
Methodology: https://510kreport.com/methodology