Cleared Traditional

K150134 - Basic, Dominant Flex, KV-6

K150134 is an FDA 510(k) clearance for Basic, manufactured by Medela AG. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K150134 · Medela AG · General & Plastic Surgery device
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Apr 2015
Decision
90d
Days
Class 2
Risk

K150134 is an FDA 510(k) clearance for the Basic, Dominant Flex, KV-6. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on April 21, 2015 after a review of 90 days - within the typical 510(k) review window.

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 Medela AG devices

FDA 510(k) Submission Details - K150134

510(k) Number K150134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2015
Decision Date April 21, 2015
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 41
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K150134.
VITRUVIAN INFILTRATION PUMP
K170629 · Black & Black Surgical, Inc. · Jun 2017
Basic, Dominant Flex
K170329 · Modela AG · Mar 2017
VITRUVIAN ULTIMATE ASPIRATOR
K161722 · Black & Black Surgical, Inc. · Jul 2016
SUCTION LIPOPLASTY ACCESSORIES
K132353 · Inex · Jul 2014
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
K121218 · Andrew Technologies, LLC · Dec 2012
MICROAIRE SURGICAL INSTRUMENTS LLC
K113128 · Microaire Surgical Instruments, LLC · Aug 2012