Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Mentor Worldwide, LLC — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

32 daysmedian FDA review time
171 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC2025-04-242110
K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant SizerMentor Worldwide, LLC2025-01-13890
K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2025-01-12300
K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC2024-09-06980
K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2024-08-02323
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC2018-09-25280
K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC2016-05-23272
K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC2016-02-191710
K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer SMentor Worldwide, LLC2015-05-20300
K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC2015-04-24302
K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC2014-12-19630
K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC2013-07-17260

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda