Cleared Traditional

AMOENA AFFINITY MODEL #802 (K915382) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K915382 · Coloplast Corp. · General & Plastic Surgery device
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Jan 1992
Decision
46d
Days
Class 1
Risk

K915382 is an FDA 510(k) clearance for the AMOENA AFFINITY MODEL #802. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on January 14, 1992 after a review of 46 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 Coloplast Corp. devices

Submission Details

510(k) Number K915382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date January 14, 1992
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCZ Prosthesis, Breast, External, 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.