Cleared Traditional

SPENCO BREAST FORMS (K896533) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K896533 · Spenco Medical Corp. · General & Plastic Surgery device
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Dec 1989
Decision
29d
Days
Class 1
Risk

K896533 is an FDA 510(k) clearance for the SPENCO BREAST FORMS. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 29 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 Spenco Medical Corp. devices

Submission Details

510(k) Number K896533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date December 13, 1989
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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.