510(k) · Cleared
ClearedNatrelle 133S Tissue Expanders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AbbVie · LCJ Tissue Expander And Accessories
Cleared on Jan 16, 2026 as substantially equivalent to K182054 (Allergan, 2018) after a 28-day review. Its family tree reaches back 4 generations to 2001. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 16, 2026
- Review
- 28 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011500 (2001). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- 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 backK143354 Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · Recalled (Class I)
- 1 generation backK182054 Natrelle 133S Tissue ExpanderAllergan · 2018
- This deviceK254126 Natrelle 133S Tissue ExpandersAbbVie · 2026
Class I recalls in this family
- K143354 Natrelle 133 Plus Tissue Expander2 generations back · 2015
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 | K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015 | Class I |
| −1 | K182054 | Natrelle 133S Tissue Expander | Allergan | 2018 | — |
| 0 (this device) | K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026 | — |
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 K242963 MENTOR™ PliaForm™ Breast Tissue Expander w/…score 10.4 · 5 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 |
|---|---|---|---|
| * | K182054 | Natrelle 133S Tissue ExpanderSummary page 5…e: Expander, Skin, Inflatable Classification Regulation: Unclassified, Pre-Amendment Product Code: LCJ Predicate Device: Natrelle® 133S Tissue Expander (K182054) Device Description: Natrelle® 133S Tissue Expanders are designed to develop tissue flaps as part of two- stage recon… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. 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/K254126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254126: Natrelle 133S Tissue Expanders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254126
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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