510(k) · Cleared
ClearedNatrelle 133S Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan · LCJ Tissue Expander And Accessories
Cleared on Aug 29, 2018 as substantially equivalent to K143354 (Allergan, Inc., 2015) after a 29-day review. Its family tree reaches back 3 generations to 2001. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 29, 2018
- Review
- 29 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011500 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- 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 backK143354 Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 2015 · Recalled (Class I)
- This deviceK182054 Natrelle 133S Tissue ExpanderAllergan · 2018
- Descendant · cites it directly · 0 of its ownK254126 Natrelle 133S Tissue ExpandersAbbVie · 2026
Class I recalls in this family
- K143354 Natrelle 133 Plus Tissue Expanderdirect predicate · 2015
Most influential descendants
Showing 1 of 1 · See all- K254126Natrelle 133S Tissue ExpandersAbbVie · 2026 · 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 | K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015 | Class I |
| 0 (this device) | K182054 | Natrelle 133S Tissue Expander | Allergan | 2018 | — |
| +1 | K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143354 | Natrelle 133 Plus Tissue ExpanderSummary page 4…Inflatable Classification Regulation: Unclassified, Pre-Amendment Product Code: LCJ III. PREDICATE DEVICE Natrelle® 133 Plus Tissue Expander (K143354) This predicate has not been subjected to a design-related recall or any type of recall. IV. REFERENCE DEVICES… | 2015 |
| † | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | 2016 |
| † | K102806 | Natrelle 133 Tissue Expander with Suture Tabs | 2011 |
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 |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | 2026 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K254126 (AbbVie, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143354.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182054: Natrelle 133S 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/K182054
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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