Cleared Traditional

K933668 - ALMOST U, INC. BREAST PROSTHESIS

K933668 is an FDA 510(k) clearance for ALMOST U, manufactured by Almost U., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCZ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K933668 · Almost U., Inc. · General & Plastic Surgery device
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Dec 1993
Decision
135d
Days
Class 1
Risk

K933668 is an FDA 510(k) clearance for the ALMOST U, INC. BREAST PROSTHESIS. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Almost U., Inc. (Peekskill, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Almost U., Inc. devices

FDA 510(k) Submission Details - K933668

510(k) Number K933668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1993
Decision Date December 10, 1993
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
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

Devices cleared under the same product code (KCZ) and FDA review panel - the closest regulatory comparables to K933668.
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