Cleared Traditional

K121005 - ADIPREP ADIPOSE TRANSFER SYSTEM

K121005 is an FDA 510(k) clearance for ADIPREP ADIPOSE TRANSFER SYSTEM, manufactured by Harvest Technologies, Corp.. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K121005 · Harvest Technologies, Corp. · General & Plastic Surgery device
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Sep 2012
Decision
171d
Days
Class 2
Risk

K121005 is an FDA 510(k) clearance for the ADIPREP ADIPOSE TRANSFER SYSTEM. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 171 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 Harvest Technologies, Corp. devices

FDA 510(k) Submission Details - K121005

510(k) Number K121005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date September 21, 2012
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MUU System, Suction, Lipoplasty

All 31
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K121005.
PUREGRAFT 50 SYSTEM
K132815 · Cytori Therapeutics, Inc. · Jan 2014
HYDRASOLVE LIPOPLASTY SYSTEM
K130152 · Andrew Technologies, LLC · Apr 2013
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
K121703 · Medi-Khan USA, Inc. · Dec 2012
ORIGINS LIPOHARVESTING SYSTEM
K120328 · Sound Surgical Technologies, LLC · Sep 2012
GID 700
K120902 · The Gid Group, Inc. · Aug 2012
PUREGRAFT 850/PURE SYSTEM
K113255 · Cytori Therapeutics, Inc. · Mar 2012