Cleared Traditional

K042054 - SILIMED PECTORAL IMPLANT

K042054 is an FDA 510(k) clearance for SILIMED PECTORAL IMPLANT, manufactured by Silimed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K042054 · Silimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
208d
Days
Class 2
Risk

K042054 is an FDA 510(k) clearance for the SILIMED PECTORAL IMPLANT. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Silimed, Inc. (Crofton, US). The FDA issued a Cleared decision on February 23, 2005 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Silimed, Inc. devices

FDA 510(k) Submission Details - K042054

510(k) Number K042054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date February 23, 2005
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 115d · This submission: 208d
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 30
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K042054.
SOFTXIL
K171851 · Bistool · Mar 2018
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504 · Implantech Associates, Inc. · Nov 2005
CALF IMPLANT, MODEL EC17-X
K052505 · Implantech Associates, Inc. · Nov 2005
SEARE BIOMEDICAL SILICONE RODS
K983630 · Seare Biomedical Corp. · Dec 1998
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688 · Spectrum Designs, Inc. · Oct 1998
SEARE BIOMEDICAL SILICONE SHEETING
K983041 · Seare Biomedical Corp. · Sep 1998