Cleared Traditional

K171286 - PAL Multi-Use Cannulas and PAL Manual Wand

K171286 is an FDA 510(k) clearance for PAL Multi-Use Cannulas and PAL Manual Wand, 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 165-day FDA review.

K171286 · Microaire Surgical Instruments, LLC · General & Plastic Surgery device
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Oct 2017
Decision
165d
Days
Class 2
Risk

K171286 is an FDA 510(k) clearance for the PAL Multi-Use Cannulas and PAL Manual Wand. 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 13, 2017 after a review of 165 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 - K171286

510(k) Number K171286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date October 13, 2017
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
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 24
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K171286.
Dermapose Access
K200168 · Puregraft, LLC · Apr 2020
VASERlipo System
K190551 · Solta Medical · May 2019
PowerX Lipo System
K190555 · Solta Medical · May 2019
Basic, Dominant Flex, KV-6
K150134 · Medela AG · Apr 2015
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · Medela AG · Feb 2007
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp. · Oct 2001