Cleared Traditional

K915382 - AMOENA AFFINITY MODEL #802

K915382 is an FDA 510(k) clearance for AMOENA AFFINITY MODEL #802, manufactured by Coloplast Corp.. The device is a Class 1 General & Plastic Surgery device with product code KCZ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

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.

FDA 510(k) Submission Details - K915382

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

KCZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - KCZ Prosthesis, Breast, External, Used With Adhesive

All 12
Devices cleared under the same product code (KCZ) and FDA review panel - the closest regulatory comparables to K915382.
CLASSIQUE
K932899 · Hemispheres Marketing Co. , Ltd. · Dec 1993
ALMOST U, INC. BREAST PROSTHESIS
K933668 · Almost U., Inc. · Dec 1993
SUOENA AFFINITY (TM) MODEL #802
K921535 · Coloplast Corp. · May 1992
YOURS TRULY ASYMMETRICAL BREAST FORM
K911247 · Jobst Institute, Inc. · Mar 1991
ELLA BREAST FORM
K904085 · Coloplast A/S · Oct 1990
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
K904316 · Coloplast Corp. · Oct 1990
K915382 · AMOENA AFFINITY MODEL #802
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