510(k) Report

FDA applicant

Mentor Corp.

Goleta, CA67 decisions1977–20138 recalls

FDA records 67 decisions for Mentor Corp. (Goleta, CA) from 1977 to 2013: 65 510(k) clearances and 2 original PMA approvals. Most are in product codes LCJ (Tissue Expander And Accessories) and FAD (Stent, Ureteral). Its devices cite 35 predicates, 12 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Mentor Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Mentor Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014: 22015: 12016: 42026 (partial year): 1
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mentor Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mentor Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LCJTissue Expander And Accessories9decisions
  • FADStent, Ureteral8decisions
  • FAEProsthesis, Penile5decisions
  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…4decisions
  • MRDMammary Sizer2decisions
  • EXJDevice, Incontinence, Urosheath Type, Sterile2decisions

Also: LJE (2), LFL (2), QPB (2), GDS (2), EZD (2), GZJ (2).

Whose devices does it build on?

Its devices cite 35 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 51 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K980483Mentor Suspend SlingMentor Corp. · 19987cite it
  • K003873Mentor Self-Cath Closed SystemMentor Corp. · 20016cite it
  • K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 19974cite it
  • K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 20054cite it
  • K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue ExpandersMentor Corp. · 20134cite it
  • K003784Mentor Self-Cath PlusMentor Corp. · 20013cite it

What has FDA decided for it lately?

  • K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue ExpandersMentor Corp. · 20134 recalls
  • P030053Memorygel Silicone Gel -Filled Breast ImplantsMentor Corp. · 20061 recall
  • K062421Mentor Resterilizable Gel Breast Implant SizerMentor Corporation · 20061 recall
  • K053414Mentor Novasilk MeshMentor Corp. · 2005
  • K053296Mentor Aris Suprapubic Surgical KitMentor Corporation · 2005
  • K052440Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation · 2005
  • K050008Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corp. · 2005
  • K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 2005

All 63 as Mentor Corp. →All 4 as Mentor Corporation →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K130813CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313…Feb 18, 2026Class II
  • K130813MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with…Aug 9, 2016Class II
  • K130813MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with…Aug 9, 2016Class II
  • K130813CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for…Aug 9, 2016Class II
  • P030053Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and…Jul 1, 2016Class II
  • K040959Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.…Apr 9, 2015Class II

Other applicant names beginning “Mentor”

FDA records each applicant name separately; these may or may not be the same firm.

Mentor O & O, Inc. 18Mentor Worldwide, LLC 14Mentor Ophthalmics, Inc. 4Mentor Medical Limited 1Mentor Urology, Inc. 1