Cleared Traditional

K030809 - HANSON MEDICAL GLUTEAL IMPLANT

K030809 is an FDA 510(k) clearance for HANSON MEDICAL GLUTEAL IMPLANT, manufactured by Hanson Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K030809 · Hanson Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
39d
Days
Class 2
Risk

K030809 is an FDA 510(k) clearance for the HANSON MEDICAL GLUTEAL IMPLANT. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Hanson Medical, Inc. (Goleta, US). The FDA issued a Cleared decision on April 21, 2003 after a review of 39 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 - K030809

510(k) Number K030809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date April 21, 2003
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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 K030809.
SILICONE BLOCK
K042380 · National Medical Devices, Inc. · Oct 2004
MEDISIL SILICONE SHEETING
K040042 · Medisil Corporation · Apr 2004
HANSON MEDICAL CALF IMPLANT
K030808 · Hanson Medical, Inc. · Apr 2003
AART CALF IMPLANT
K022511 · Aesthetic and Reconstructive Technologies, Inc. · Aug 2002
AART SILICONE SHEETING
K022223 · Aesthetic and Reconstructive Technologies, Inc. · Aug 2002
AART SILICONE CARVING BLOCK
K021820 · Aesthetic and Reconstructive Technologies, Inc. · Jul 2002