Cleared Abbreviated

K032802 - HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III

K032802 is an FDA 510(k) clearance for HK LIPOSUCTION ASPIRATOR, manufactured by Hk Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K032802 · Hk Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
71d
Days
Class 2
Risk

K032802 is an FDA 510(k) clearance for the HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Hk Surgical, Inc. (Oceanside, US). The FDA issued a Cleared decision on November 19, 2003 after a review of 71 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K032802

510(k) Number K032802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date November 19, 2003
Days to Decision 71 days
Submission Type Abbreviated
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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

QPB Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K032802.
SORING GMBH SONOCA LIPO
K052183 · Soring GmbH Medizintechnik · Oct 2005
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · Macropore Biosurgery, Inc. · Sep 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · Misonix, Inc. · May 2004
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · Biosculpture Technology, Inc. · Jul 2003
SOUNDVASER SYSTEM
K022051 · Sound Surgical Technologies, LLC · Sep 2002
STARS2000 POWER CANNULA
K012236 · Kmi Kolster Methods, Inc. · Nov 2001
K032802 · HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
Download PDF FDA Summary Hk Surgical, Inc.