Cleared Traditional

K220318 - PAL Infiltration System

K220318 is an FDA 510(k) clearance for PAL Infiltration System, manufactured by Microaire Surgical Instruments, LLC. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K220318 · Microaire Surgical Instruments, LLC · General & Plastic Surgery device
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Oct 2022
Decision
253d
Days
Class 2
Risk

K220318 is an FDA 510(k) clearance for the PAL Infiltration System. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on October 14, 2022 after a review of 253 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Microaire Surgical Instruments, LLC devices

FDA 510(k) Submission Details - K220318

510(k) Number K220318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2022
Decision Date October 14, 2022
Days to Decision 253 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 115d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPB Device Classification - Class 2, Special Controls

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 23
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K220318.
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835 · Cellmyx · Nov 2024
Vitruvian Liposaber
K240188 · Black & Black Surgical, Inc. · Sep 2024
Liposaver
K212969 · Lhbiomed Co., Ltd. · Aug 2024
PAL System
K212024 · Microaire Surgical Instruments, LLC · Jun 2022
PAL Single-Use Cannulas
K192694 · Microaire Surgical Instruments · May 2020
Dermapose Access
K200168 · Puregraft, LLC · Apr 2020