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

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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