510(k) · Cleared
ClearedMentor™ 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 Jan 12, 2025 as substantially equivalent to K241918 (Mentor Worldwide, LLC, 2024) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 12, 2025
- Review
- 30 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011500 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011500 Mentor Contour Profile Tissue ExpanderMentor Corp. · 2001
- 3 generations backK130813 Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture…Mentor Corp. · 2013 · Recalled
- 2 generations backK152496 CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC · 2016
- 1 generation backK241918 MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2024 · Recalled
- This deviceK243836 Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011500 | Mentor Contour Profile Tissue Expander | Mentor Corp. | 2001 | — |
| −3 | K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… | Mentor Corp. | 2013 | 4 |
| −2 | K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016 | — |
| −1 | K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024 | 3 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderSummary page 5…Unclassified, Pre-Amendment Panel: General & Plastic Surgery Product Code: LCJ III. PREDICATE DEVICE K241918, Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes up to 1445cc This predicate has not been subje… | 2024 |
| * | K152496 | CPX 4 Breast Tissue ExpanderSummary page 5…Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes up to 1445cc This predicate has not been subjected to a design-related recall. K152496, Mentor™ CPX™4 Breast Tissue Expander with fill volumes up to 1445cc This predicate has not been subjected to a design-rel… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K243836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243836: 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/K243836
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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