Mentor Worldwide, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Mentor Worldwide, LLC” (first 2013, latest 2025), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 60 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 26 |
| 2014 | 1 | 63 |
| 2015 | 2 | 30 |
| 2016 | 2 | 99 |
| 2017 | 0 | — |
| 2018 | 1 | 28 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 65 |
| 2025 | 3 | 89 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mentor Worldwide, LLC took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | 8 | 8 |
| MRD | Mammary Sizer | 4 | 4 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 1 | 0 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 1 | 0 |
Review panels
Most recent Mentor Worldwide, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | LCJ | 2025-04-24 | 211 |
| K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | MRD | 2025-01-13 | 89 |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | LCJ | 2025-01-12 | 30 |
| K241552 | MENTOR MemoryGel Enhance Single Use Gel Sizer | MRD | 2024-09-06 | 98 |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | LCJ | 2024-08-02 | 32 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | LCJ | 2018-09-25 | 28 |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | LCJ | 2016-05-23 | 27 |
| K152496 | CPX 4 Breast Tissue Expander | LCJ | 2016-02-19 | 171 |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | MRD | 2015-05-20 | 30 |
| K150777 | Artoura Breast Tissue Expander | LCJ | 2015-04-24 | 30 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060028 | PMA | MENTOR MEMORYSHAPE BREAST IMPLANTS | 2013-06-14 |
| P990075 | PMA | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | 2000-05-10 |
Recalls
openFDA lists no recalls under a recalling firm named Mentor Worldwide, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mentor Worldwide, LLC is the lead sponsor of 7 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT02919592: Memory Gel and Shape Combined Cohort (Active not recruiting, started 2016-09-01)
- NCT02724371: A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Active not recruiting, started 2016-04-01)
- NCT01959880: CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study) (Completed, started 2013-08)
- NCT00756652: Mentor MemoryGel Post-Approval Study (Completed, started 2006-11-01)
- NCT00764257: PREVELLE Shape (CX002) Dermal Filler Protocol (Completed, started 2004-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mentor Corp. (65 510(k)s)
- Mentor O & O, Inc. (18 510(k)s)
- Mentor Ophthalmics, Inc. (4 510(k)s)
- Mentor Medical Limited (1 510(k)s)
- Mentor Urology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mentor Worldwide, LLC?
FDA lists 12 510(k) clearances under the applicant name “Mentor Worldwide, LLC” (first 2013, latest 2025), plus 2 PMA decisions, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mentor Worldwide, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mentor Worldwide, LLC is 31 days. Since 2017: 60 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mentor Worldwide, LLC?
The most frequent FDA product codes under this applicant name are LCJ (Tissue Expander And Accessories, 8); MRD (Mammary Sizer, 4); FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled, 1).
Next steps
- See all 12 Mentor Worldwide, LLC clearances with predicates and recalls
- Run predicate analysis for product code LCJ, Mentor Worldwide, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.