510(k) · Cleared
Recalled · Class I · 2019Natrelle 133 Tissue Expander with Suture Tabs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan Medical · LCJ Tissue Expander And Accessories
Cleared on Jan 5, 2011 as substantially equivalent to K862203 (Mcghan Medical Corp., 1986) after a 99-day review. Its family tree reaches back 1 generation to 1986. 2 of the 3 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jan 5, 2011
- Review
- 99 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862203 (1986). 1 later device descends from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK862203 Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986 · Recalled (Class I)
- This deviceK102806 Natrelle 133 Tissue Expander with Suture TabsAllergan Medical · 2011
- Descendant · cites it directly · 0 of its ownK112534 Lifecell Tissue ExpanderLifecell Corp. · 2012
Class I recalls in this family
- K862203 Mcghan Magna-Site (TM) Tissue Expanderdirect predicate · 1986
Most influential descendants
Showing 1 of 1 · See all- K112534Lifecell Tissue ExpanderLifecell Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862203 | Mcghan Magna-Site (TM) Tissue Expander | Mcghan Medical Corp. | 1986 | Class I |
| 0 (this device) | K102806 | Natrelle 133 Tissue Expander with Suture Tabs | Allergan Medical | 2011 | — |
| +1 | K112534 | Lifecell Tissue Expander | Lifecell Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K862203 | Mcghan Magna-Site (TM) Tissue ExpanderSummary page 1…xpander, Skin, Inflatable Classification Regulation: LCJ (Unclassified) Predicate NATRELLEO Style 133 Series Tissue Expander Matrix (K862203) Devices: Device Allergan's Tissue Expanders are constructed from silicone elastomer and Description: consist of an… | 1986 |
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 |
|---|---|---|---|
| K112534 | Lifecell Tissue Expander | 2012 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2019 | Class I | Z-2455-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
| Jul 24, 2019 | Class I | Z-2457-2019 | Unknown/Undetermined by firm | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. |
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.
- K862203Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102806: Natrelle 133 Tissue Expander with Suture Tabs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102806
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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