Cleared Traditional

K842765 - SILIMED BREAST FORM

K842765 is an FDA 510(k) clearance for SILIMED BREAST FORM, manufactured by Sil-Med Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K842765 · Sil-Med Corp. · General & Plastic Surgery device
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Aug 1984
Decision
32d
Days
Class 1
Risk

K842765 is an FDA 510(k) clearance for the SILIMED BREAST FORM. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Sil-Med Corp. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - 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 - K842765

510(k) Number K842765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date August 17, 1984
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

GBI Device Classification - Class 1, General Controls

Product Code GBI Material, External Aesthetic Restoration, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBI Material, External Aesthetic Restoration, Used With Adhesive

All 16
Devices cleared under the same product code (GBI) and FDA review panel - the closest regulatory comparables to K842765.
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · Coloplast Corp. · Jan 1987
AMOENA BREAST FORMS
K853822 · Coloplast Corp. · Sep 1985
PROSTHESIS OR SURGICAL PADS
K851668 · Virginia Hall, Inc. · Jun 1985
CONFORMA
K841559 · Beiersdorf, Inc. · Jul 1984
TRILICON BREASE PROSTHESIS DIFFERENT
K841171 · Baurs Krey Assoc., Inc. · Apr 1984
PDM SILOXANE PROSTHETIC ORBIT
K832151 · Delaware Prosthetics, Inc. · Dec 1983
K842765 · SILIMED BREAST FORM
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