Cleared Traditional

K212024 - PAL System

K212024 is an FDA 510(k) clearance for PAL 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 346-day FDA review.

K212024 · Microaire Surgical Instruments, LLC · General & Plastic Surgery device
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Jun 2022
Decision
346d
Days
Class 2
Risk

K212024 is an FDA 510(k) clearance for the PAL 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 June 10, 2022 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K212024

510(k) Number K212024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2021
Decision Date June 10, 2022
Days to Decision 346 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
231d slower than avg
Panel avg: 115d · This submission: 346d
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 K212024.
Vitruvian Liposaber
K240188 · Black & Black Surgical, Inc. · Sep 2024
Liposaver
K212969 · Lhbiomed Co., Ltd. · Aug 2024
PAL Infiltration System
K220318 · Microaire Surgical Instruments, LLC · Oct 2022
PAL Single-Use Cannulas
K192694 · Microaire Surgical Instruments · May 2020
Dermapose Access
K200168 · Puregraft, LLC · Apr 2020
VASERlipo System
K190551 · Solta Medical · May 2019