Cleared Traditional

PAL Single-Use Cannulas (K192694) - FDA 510(k) Clearance

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

K192694 · Microaire Surgical Instruments · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2020
Decision
231d
Days
Class 2
Risk

K192694 is an FDA 510(k) clearance for the PAL Single-Use Cannulas. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Microaire Surgical Instruments (Charlottesville, US). The FDA issued a Cleared decision on May 14, 2020 after a review of 231 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 devices

Submission Details

510(k) Number K192694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date May 14, 2020
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
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 Consultant

Barile & Associates, Inc.
Diane Sudduth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 13
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K192694.
Liposaver
K212969 · Lhbiomed Co., Ltd. · Aug 2024
PAL Infiltration System
K220318 · Microaire Surgical Instruments, LLC · Oct 2022
PAL System
K212024 · Microaire Surgical Instruments, LLC · Jun 2022
Dermapose Access
K200168 · Puregraft, LLC · Apr 2020
VASERlipo System
K190551 · Solta Medical · May 2019
PowerX Lipo System
K190555 · Solta Medical · May 2019