Cleared Traditional

CPX Control Breast Tissue Expander (K142998) - FDA 510(k) Clearance

K142998 · Mentor Worldwide, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
63d
Days
-
Risk

K142998 is an FDA 510(k) clearance for the CPX Control Breast Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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Submission Details

510(k) Number K142998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2014
Decision Date December 19, 2014
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -