# Mentor Worldwide, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 14 (2000–2025): 12 510(k) clearances and 2 original PMA approvals
- Product codes: LCJ (8), MRD (4), FTR (1), FWM (1)
- 510(k) review time since 2016: median 28 days, against 153 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 16 (11 its own); citations of its devices by later devices: 13 (11 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mentor Corp.: 5 (https://510kreport.com/company/mentor)

## Firms that cite its devices most
- Motiva USA, LLC: 1 (https://510kreport.com/company/motiva-usa)
- Microaire Surgical Instruments, LLC: 1 (https://510kreport.com/company/microaire-surgical-instruments)

## Its most-cited devices
- K131853: Mentor Memoryshape Resterilizable Gel Sizer (2013), cited by 2
- K151055: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (2015), cited by 2
- K152496: CPX 4 Breast Tissue Expander (2016), cited by 2
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface (2016), cited by 2
- K182335: CPX 4 Breast Tissue Expander with Smooth Surface (2018), cited by 1
- K150777: Artoura Breast Tissue Expander (2015), cited by 1

## Recent decisions
- K242963: MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (Apr 24, 2025)
- K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (Jan 13, 2025)
- K243836: Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (Jan 12, 2025)
- K241552: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (Sep 6, 2024)
- K241918: MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (Aug 2, 2024)
- K182335: CPX 4 Breast Tissue Expander with Smooth Surface (Sep 25, 2018)
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface (May 23, 2016)
- K152496: CPX 4 Breast Tissue Expander (Feb 19, 2016)

Source page: https://510kreport.com/company/mentor-worldwide