Cleared Traditional

K212024 - PAL System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
232d slower than avg
Panel avg: 114d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K212024.
LSSA (NP-200)
K252495 · Newpong Co., Ltd. · Apr 2026
AYON Body Contouring System (AYON SYSTEM)
K244050 · Apyx Medical Corporation · May 2025
PAL 7020 Console
K244026 · Microaire Surgical Instruments, LLC · Apr 2025
PAL Aspiration System
K242804 · Microaire Surgical Instruments, LLC · Dec 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835 · Cellmyx · Nov 2024
Vitruvian Liposaber
K240188 · Black & Black Surgical, Inc. · Sep 2024