510(k) · Cleared
Recalled · Class II · 2026Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · LCJ Tissue Expander And Accessories
Cleared on Apr 11, 2013 as substantially equivalent to K011500 (Mentor Corp., 2001) after a 17-day review. Its family tree reaches back 1 generation to 2001. 1 of the 15 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 11, 2013
- Review
- 17 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011500 (2001). 13 later devices descend from it, 4 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- This deviceK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013
- Descendant · cites it directly · 4 of its ownK142998 CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014
- Descendant · cites it directly · 3 of its ownK143354 Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK150777 Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK182335 CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK161176 ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K143354 Natrelle 133 Plus Tissue Expandercites it directly · 2015
Most influential descendants
Showing 5 of 13 · See all- K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC · 2014 · cites it directly4descendants
- K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · cites it directly3descendants
- K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC · 2015 · 2 generations on3descendants
- K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC · 2018 · cites it directly2descendants
- K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| 0 (this device) | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | — |
| +1 | K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014 | — |
| +1 | K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015 | Class I |
| +2 | K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015 | 2 |
| +1 | K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | 2018 | — |
| +3 | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011500 | Mentor Contour Profile Tissue ExpanderSummary page 1…Unclassified, Pre-Amendment Panel: General & Plastic Surgery Product Code: LCJ Predicate Device: K01 1500, Mentor Contour Profile Tissue Expander Indication for Use: The Contour Profile Tissue Expanders can be utilized for breast reco… | 2001 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2026 | Class II | Z-1681-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Aug 9, 2016 | Class II | Z-2748-2016 | Employee error | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc |
| Aug 9, 2016 | Class II | Z-2747-2016 | Employee error | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc |
| Aug 9, 2016 | Class II | Z-2781-2016 | Employee error | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. |
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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K142998 (Mentor Worldwide, LLC, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LCJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCJ
525in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCJ
496in 2025
MAUDE reports naming product code LCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 10 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 58 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 31 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 3 | 256 | 0 | 20 |
| 2015 | 2 | — | 0 | 13 |
| 2016 | 3 | 153 | 0 | 38 |
| 2017 | 0 | — | 0 | 111 |
| 2018 | 3 | 29 | 0 | 518 |
| 2019 | 0 | — | 0 | 554 |
| 2020 | 0 | — | 0 | 639 |
| 2021 | 0 | — | 0 | 440 |
| 2022 | 0 | — | 0 | 499 |
| 2023 | 3 | 525 | 1 | 473 |
| 2024 | 1 | — | 0 | 488 |
| 2025 | 2 | — | 0 | 496 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Contour Profile Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130813
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026