Cleared Traditional

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K951324 · Maxol Limited L.C. · General & Plastic Surgery device
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May 1995
Decision
64d
Days
Class 1
Risk

K951324 is an FDA 510(k) clearance for the MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Maxol Limited L.C. (Overland Park, US). The FDA issued a Cleared decision on May 26, 1995 after a review of 64 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 Maxol Limited L.C. devices

Submission Details

510(k) Number K951324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1995
Decision Date May 26, 1995
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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.