510(k) · Cleared
Recalled · Class II · 2026MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Worldwide, LLC · LCJ Tissue Expander And Accessories
Cleared on Aug 2, 2024 as substantially equivalent to K152496 (Mentor Worldwide, LLC, 2016) and 1 other predicate after a 32-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Aug 2, 2024
- Review
- 32 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011500 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- 2 generations backK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
- 1 generation backK152496 CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC · 2016
- This deviceK241918 MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2024
- Descendant · cites it directly · 0 of its ownK243836 Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| −2 | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | 4 |
| −1 | K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016 | — |
| 0 (this device) | K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024 | — |
| +1 | K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
Planning a device in LCJ? 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? (2)
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 |
|---|---|---|---|
| * | K152496 | CPX 4 Breast Tissue ExpanderSummary page 5…Panel: General & Plastic Surgery Product Code: LCJ III. PREDICATE DEVICE Primary Predicate K152496, Mentor™ CPX™4 Breast Tissue Expander with fill volumes up to 1445cc This predicate has not been subjected to a design-… | 2016 |
| * | K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceSummary page 5…east Tissue Expander with fill volumes up to 1445cc This predicate has not been subjected to a design-related recall. Additional Predicate K182335, Mentor™ CPX™ 4 Breast Tissue Expander with Smooth Surface This predicate has not been subjected to a design-related re… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2026 | Class II | Z-1682-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Feb 18, 2026 | Class II | Z-1684-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Feb 18, 2026 | Class II | Z-1683-2026 | Under Investigation by firm | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243836 (Mentor Worldwide, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152496.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241918: MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241918
Report an extraction error
Are you the manufacturer?
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