510(k) Report

510(k) · Cleared

Cleared

Mentor Contour Profile Tissue Expander

K011500510(k) TraditionalCleared Dec 3, 2001201-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mentor Corp. · LCJ Tissue Expander And Accessories

Cleared on Dec 3, 2001 after a 201-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.

Decided
Dec 3, 2001
Review
201 days
Class
Class U
Product code
LCJ
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2013: 1 descendant cleared2018: 3 descendants cleared2015: 2 descendants cleared, 1 with a Class I recall12016: 2 descendants cleared2014: 1 descendant cleared2025: 3 descendants cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
  2. Descendant · cites it directly · 13 of its ownK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK142998 CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014
  4. Descendant · 2 generations on · 3 of its ownK143354 Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · Recalled (Class I)
  5. Descendant · 3 generations on · 3 of its ownK150777 Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK182335 CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 22016: 22018: 32024: 12025: 32026: 1
2013high 3 (2018) · low 0 (2017)2026

Class I recalls in this family

  • K143354 Natrelle 133 Plus Tissue Expander2 generations on · 2015

Most influential descendants

Showing 5 of 14 · See all
  • K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…Mentor Corp. · 2013 · cites it directly13descendants
  • K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014 · 2 generations on4descendants
  • K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · 2 generations on3descendants
  • K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · 3 generations on3descendants
  • K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC · 2018 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011500Mentor Contour Profile Tissue ExpanderMentor Corp.2001—
+1K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast…Mentor Corp.20134
+2K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC2014—
+2K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc.2015Class I
+3K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC20152
+2K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201521
201620
201830
202410
202530
202610
FIG. 1 — Lineage of K011500, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LCJ device

  1. #1 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…Mentor Corp.201313

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K130813 (Mentor Corp., 2013) has gone furthest, with 13 descendants of its own.

How does its category compare?

All LCJ devices

LCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCJ

2in 2025

2007: 12011: 12012: 12013: 12014: 32015: 22016: 32018: 32023: 32024: 12025: 22026 (partial year): 1
2007high 3 (2014) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCJ

525in 2023

2014: 256 days median2016: 153 days median2018: 29 days median2023: 525 days median
2007high 525 (2023) · low 29 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCJ

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LCJ

496in 2025

2007: 102008: 242009: 212010: 582011: 162012: 312013: 472014: 202015: 132016: 382017: 1112018: 5182019: 5542020: 6392021: 4402022: 4992023: 4732024: 4882025: 496
2007high 639 (2020) · low 10 (2007)2025

MAUDE reports naming product code LCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—010
20080—024
20090—021
20100—058
20111—016
20121—031
20131—047
20143256020
20152—013
20163153038
20170—0111
20183290518
20190—0554
20200—0639
20210—0440
20220—0499
202335251473
20241—0488
20252—0496
20261—0—

More from Mentor Corp.

146 FDA decisions under this applicant name. See the company

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  • P030053/S085MENTOR™ MemoryGel™ Breast ImplantsMentor Corp. · 2026
  • P030053/S083MENTOR™ MemoryGel™ Enhance Breast ImplantsMentor Corp. · 2026
  • P030053/S089MENTOR™ MemoryGel™ Silicone Gel-Filled Breast ImplantsMentor Corp. · 2026
  • P030053/S088MemoryGel Silicone Gel-Filled Breast ImplantMentor Corp. · 2026

Recent decisions in LCJ

The LCJ category page

  • K254126Natrelle 133S Tissue ExpandersAbbVie · 2026
  • K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC · 2025
  • K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2025
  • K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 20243 recalls
  • K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC · 2023

https://510kreport.com/device/K011500 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011500: Mentor Contour Profile Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011500

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026