Cleared Traditional

K042380 - SILICONE BLOCK

K042380 is an FDA 510(k) clearance for SILICONE BLOCK, manufactured by National Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K042380 · National Medical Devices, Inc. · General & Plastic Surgery device
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Oct 2004
Decision
54d
Days
Class 2
Risk

K042380 is an FDA 510(k) clearance for the SILICONE BLOCK. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by National Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on October 25, 2004 after a review of 54 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.

View all National Medical Devices, Inc. devices

FDA 510(k) Submission Details - K042380

510(k) Number K042380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date October 25, 2004
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 K042380.
SOFTXIL
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K983041 · Seare Biomedical Corp. · Sep 1998