Cleared Traditional

K210528 - IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210528 · Millennium Medical Technologies Inc (Dba Cellmyx) · General & Plastic Surgery device
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Mar 2022
Decision
386d
Days
Class 2
Risk

K210528 is an FDA 510(k) clearance for the IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat .... Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Millennium Medical Technologies Inc (Dba Cellmyx) (Carlsbad, US). The FDA issued a Cleared decision on March 16, 2022 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Millennium Medical Technologies Inc (Dba Cellmyx) devices

Submission Details

510(k) Number K210528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2021
Decision Date March 16, 2022
Days to Decision 386 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
272d slower than avg
Panel avg: 114d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Cellmyx
Jacqueline Hauge

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.