Mentor Corp.: FDA filings under this applicant name
FDA lists 65 510(k) clearances under the applicant name “Mentor Corp.” (first 1977, latest 2013), plus 2 PMA decisions, across 36 product codes in 8 review panels. Median 510(k) review time under this name: 67 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 17 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | 9 | 9 |
| FAD | Stent, Ureteral | 8 | 8 |
| FAE | Prosthesis, Penile | 5 | 5 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 4 | 4 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 | 2 |
| EZD | Catheter, Straight | 2 | 2 |
| GDS | Bag, Stomal | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
Plus 26 more product codes.
Review panels
- Gastroenterology and Urology (34)
- General and Plastic Surgery (22)
- Obstetrics and Gynecology (3)
- Neurology (2)
- Physical Medicine (2)
- General Hospital (1)
- Ophthalmic (1)
- Radiology (1)
Most recent Mentor Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | LCJ | 2013-04-11 | 17 |
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | MRD | 2006-10-10 | 53 |
| K053414 | MENTOR NOVASILK MESH | OTP | 2005-12-27 | 20 |
| K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | OTN | 2005-12-15 | 20 |
| K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | EZD | 2005-10-11 | 35 |
| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | EZD | 2005-06-03 | 151 |
| K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | OTN | 2005-03-09 | 44 |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | OTN | 2004-11-09 | 25 |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | FAE | 2004-10-29 | 199 |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | OTN | 2003-07-17 | 38 |
55 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030053 | PMA | MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS | 2006-11-17 |
| P850053 | PMA | FIBREL | 1988-02-26 |
Recalls
openFDA lists no recalls under a recalling firm named Mentor Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Mentor Corp. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
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 O & O, Inc. (18 510(k)s)
- Mentor Worldwide, LLC (12 510(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 Corp.?
FDA lists 65 510(k) clearances under the applicant name “Mentor Corp.” (first 1977, latest 2013), plus 2 PMA decisions, across 36 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mentor Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mentor Corp. is 67 days.
Which FDA product codes appear under Mentor Corp.?
The most frequent FDA product codes under this applicant name are LCJ (Tissue Expander And Accessories, 9); FAD (Stent, Ureteral, 8); FAE (Prosthesis, Penile, 5).
Next steps
- See all 65 Mentor Corp. clearances with predicates and recalls
- Run predicate analysis for product code LCJ, Mentor Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.