Cleared Abbreviated

K032802 - HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032802 · Hk Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Hk Surgical, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 114d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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 56
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K032802.
AYON Body Contouring System™ (AYON SYSTEM)
K253396 · Apyx Medical Corporation · May 2026
LSSA (NP-200)
K252495 · Newpong Co., Ltd. · Apr 2026
AYON Body Contouring System (AYON SYSTEM)
K244050 · Apyx Medical Corporation · May 2025
PAL 7020 Console
K244026 · Microaire Surgical Instruments, LLC · Apr 2025
PAL Aspiration System
K242804 · Microaire Surgical Instruments, LLC · Dec 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835 · Cellmyx · Nov 2024