Cleared Traditional

K010666 - XPS 3000 SYSTEM WITH RECIPROCATING ADAP...

K010666 is the FDA 510(k) clearance for XPS 3000 SYSTEM WITH RECIPROCATING ADAP... by Medtronic Xomed, Inc.. It is a Class 2 General & Plastic Surgery device (product code QPB) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K010666 · Medtronic Xomed, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
62d
Days
Class 2
Risk

K010666 is an FDA 510(k) clearance for the XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 7, 2001 after a review of 62 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 Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K010666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date May 07, 2001
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
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 - QPB System, Suction, Lipoplasty For Removal

All 18
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K010666.
VASERlipo System
K190551 · Solta Medical · May 2019
PowerX Lipo System
K190555 · Solta Medical · May 2019
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp. · Oct 2001
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · Xomed, Inc. · Jan 2000
MICRO-FRANCE LIPOSUCTION CANNULAS
K992282 · Xomed, Inc. · Sep 1999
MENTOR PATHWAY INTRODUCER/DILATOR
K981527 · Mentor Corp. · Jul 1998