Cleared Traditional

K150156 - Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel

K150156 is an FDA 510(k) clearance for Ranfac Fat Aspiration Transfer Syringe ..., manufactured by Ranfac, Corp.. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K150156 · Ranfac, Corp. · General & Plastic Surgery device
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Oct 2015
Decision
269d
Days
Class 2
Risk

K150156 is an FDA 510(k) clearance for the Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspi.... Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on October 19, 2015 after a review of 269 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 Ranfac, Corp. devices

FDA 510(k) Submission Details - K150156

510(k) Number K150156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date October 19, 2015
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
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 20
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K150156.
Alma LipoFlow System
K171242 · Alma Lasers, Inc. · Jul 2017
Lipogems System
K171135 · Lipogems International Spa · May 2017
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
K170449 · Millennium Medical Technologies, Inc. · Mar 2017
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
K121703 · Medi-Khan USA, Inc. · Dec 2012
ADIPREP ADIPOSE TRANSFER SYSTEM
K121005 · Harvest Technologies, Corp. · Sep 2012
ORIGINS LIPOHARVESTING SYSTEM
K120328 · Sound Surgical Technologies, LLC · Sep 2012