Cleared Traditional

K170449 - 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 (FDA 510(k) Clearance)

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

K170449 · Millennium Medical Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2017
Decision
44d
Days
Class 2
Risk

K170449 is an FDA 510(k) clearance for the Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 an.... Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Millennium Medical Technologies, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 31, 2017 after a review of 44 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.

View all Millennium Medical Technologies, Inc. devices

Submission Details

510(k) Number K170449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2017
Decision Date March 31, 2017
Days to Decision 44 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
70d faster than avg
Panel avg: 114d · This submission: 44d
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.