Cleared Traditional

K170329 - Basic, Dominant Flex

K170329 is an FDA 510(k) clearance for Basic, manufactured by Modela AG. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K170329 · Modela AG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
50d
Days
Class 2
Risk

K170329 is an FDA 510(k) clearance for the Basic, Dominant Flex. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Modela AG (Baar, CH). The FDA issued a Cleared decision on March 24, 2017 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K170329

510(k) Number K170329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2017
Decision Date March 24, 2017
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 Consultant

Pathway Regulatory Consulting, LLC
Adrienne Lenz

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 59
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K170329.
PowerX Lipo System
K190555 · Solta Medical · May 2019
PAL Multi-Use Cannulas and PAL Manual Wand
K171286 · Microaire Surgical Instruments, LLC · Oct 2017
VITRUVIAN INFILTRATION PUMP
K170629 · Black & Black Surgical, Inc. · Jun 2017
VITRUVIAN ULTIMATE ASPIRATOR
K161722 · Black & Black Surgical, Inc. · Jul 2016
Basic, Dominant Flex, KV-6
K150134 · Medela AG · Apr 2015
SUCTION LIPOPLASTY ACCESSORIES
K132353 · Inex · Jul 2014
K170329 · Basic, Dominant Flex
Download PDF FDA Summary Modela AG