Cleared Traditional

EXTERNAL BREAST PROSTHESIS (K813416) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K813416 · Surgical Appliance Industries, Inc. · General & Plastic Surgery device
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Jan 1982
Decision
42d
Days
Class 1
Risk

K813416 is an FDA 510(k) clearance for the EXTERNAL BREAST PROSTHESIS. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 42 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.

View all Surgical Appliance Industries, Inc. devices

Submission Details

510(k) Number K813416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date January 18, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.