Cleared Traditional

K101713 - LIPCOLLECTOR II

K101713 is an FDA 510(k) clearance for LIPCOLLECTOR II, manufactured by Human Med AG. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K101713 · Human Med AG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
11d
Days
Class 2
Risk

K101713 is an FDA 510(k) clearance for the LIPCOLLECTOR II. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Human Med AG (Schwerin, DE). The FDA issued a Cleared decision on June 29, 2010 after a review of 11 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 - K101713

510(k) Number K101713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date June 29, 2010
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MUU Device Classification - Class 2, Special Controls

Product Code MUU System, Suction, Lipoplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition See Federal Register Notice At 86 Fr 50887 “consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article” (frn) (fda-2021-n-0881).
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

Tuv Sud America, Inc.
STEFAN PREISS

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 - MUU System, Suction, Lipoplasty

All 39
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K101713.
PUREGRAFT 850/PURE SYSTEM
K113255 · Cytori Therapeutics, Inc. · Mar 2012
FAT CONCENTRATION SYSTEM
K100114 · Biomet, Inc. · Sep 2010
TISSU TRANS FILTRON SYRINGE FILL
K102117 · Shippert Medical Technologies Corp. · Aug 2010
CYTORI PUREGRAFT 250/PURE SYSTEM
K092923 · Cytori Therapeutics, Inc. · Jan 2010
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
K092482 · Shippert Medical Technologies Corp. · Dec 2009
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
K092284 · Medical Device Resource Corp. · Sep 2009

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K101713 · LIPCOLLECTOR II
Download PDF FDA Summary Human Med AG