Cleared Traditional

K853822 - AMOENA BREAST FORMS

K853822 is an FDA 510(k) clearance for AMOENA BREAST FORMS, manufactured by Coloplast Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBI cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K853822 · Coloplast Corp. · General & Plastic Surgery device
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Sep 1985
Decision
17d
Days
Class 1
Risk

K853822 is an FDA 510(k) clearance for the AMOENA BREAST FORMS. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on September 30, 1985 after a review of 17 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

FDA 510(k) Submission Details - K853822

510(k) Number K853822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1985
Decision Date September 30, 1985
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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

Devices cleared under the same product code (GBI) and FDA review panel - the closest regulatory comparables to K853822.
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
K872714 · Roseburg SA · Jul 1987
AMOENA BREAST FORMS
K864785 · Coloplast Corp. · Jan 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · Coloplast Corp. · Jan 1987
SILIMED BREAST FORM
K842765 · Sil-Med Corp. · Aug 1984
CONFORMA
K841559 · Beiersdorf, Inc. · Jul 1984