Cleared Traditional

K960038 - SPECTRUM DESIGNS SILICONE BLOCK

K960038 is an FDA 510(k) clearance for SPECTRUM DESIGNS SILICONE BLOCK, manufactured by Spectrum Designs, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K960038 · Spectrum Designs, Inc. · General & Plastic Surgery device
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Mar 1996
Decision
70d
Days
Class 2
Risk

K960038 is an FDA 510(k) clearance for the SPECTRUM DESIGNS SILICONE BLOCK. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 70 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 Spectrum Designs, Inc. devices

FDA 510(k) Submission Details - K960038

510(k) Number K960038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1996
Decision Date March 13, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
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 12
Devices cleared under the same product code (MIB) and FDA review panel - the closest regulatory comparables to K960038.
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
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688 · Spectrum Designs, Inc. · Oct 1998
ZARA SILICONE BLOCK
K913882 · Byron Medical · Apr 1992