Cleared Traditional

K142998 - CPX Control Breast Tissue Expander

K142998 · Mentor Worldwide, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
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.

View all Mentor Worldwide, LLC devices

FDA 510(k) Submission Details - K142998

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.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 25
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K142998.
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · Mentor Worldwide, LLC · Sep 2018
Natrelle 133S Tissue Expander
K182054 · Allergan · Aug 2018
Natrelle 133 Plus Tissue Expander
K143354 · Allergan, Inc. · Aug 2015
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996