Cleared Traditional

K022223 - AART SILICONE SHEETING

K022223 is an FDA 510(k) clearance for AART SILICONE SHEETING, manufactured by Aesthetic and Reconstructive Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K022223 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
30d
Days
Class 2
Risk

K022223 is an FDA 510(k) clearance for the AART SILICONE SHEETING. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on August 8, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - 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.

FDA 510(k) Submission Details - K022223

510(k) Number K022223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2002
Decision Date August 08, 2002
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIB Device Classification - Class 2, Special Controls

Product Code MIB Elastomer, Silicone Block
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 - MIB Elastomer, Silicone Block

All 44
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K022223.
HANSON MEDICAL CALF IMPLANT
K030808 · Hanson Medical, Inc. · Apr 2003
HANSON MEDICAL GLUTEAL IMPLANT
K030809 · Hanson Medical, Inc. · Apr 2003
AART CALF IMPLANT
K022511 · Aesthetic and Reconstructive Technologies, Inc. · Aug 2002
AART SILICONE CARVING BLOCK
K021820 · Aesthetic and Reconstructive Technologies, Inc. · Jul 2002
AART GLUTEAL IMPLANT
K021839 · Aesthetic and Reconstructive Technologies, Inc. · Jul 2002
SEARE BIOMEDICAL SILICONE RODS
K983630 · Seare Biomedical Corp. · Dec 1998
K022223 · AART SILICONE SHEETING
Download PDF FDA Summary Aesthetic and Reconst…